Company · GB
ConvaTec, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (2 in 12 months)
72recalls (5 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BYG | Mask, Oxygen | 19 |
| KOD | Catheter, Urological | 10 |
| FRO | Dressing, Wound, Drug | 9 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 9 |
| EZQ | Pouch, Colostomy | 8 |
| EZD | Catheter, Straight | 6 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 6 |
| FON | Bag, Drainage, With Adhesive, Ostomy | 5 |
| EXB | Collector, Ostomy | 4 |
| EXE | Protector, Ostomy | 3 |
| LNO | 3 | |
| NAD | Dressing, Wound, Occlusive | 3 |
| GBM | Catheter, Urethral | 2 |
| BYL | Tent, Oxygen | 1 |
| DRX | Electrode, Electrocardiograph | 1 |
| EXG | Bag, Urine Collecting, Ureterostomy | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 |
| FPD | Tube, Feeding | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2026 | K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Inte Convatec, GB | EZD |
| Apr 1, 2026 | K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women Convatec Limited, GB | EZD |
| Jul 1, 2025 | K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Convatec, GB | EZD |
| Jun 6, 2025 | K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter I Convatec Limited, GB | FCM |
| Mar 28, 2025 | K243228 | Flexi-Seal AIR (with ENFit Connector) Convatec, GB | KNT |
| Jan 25, 2024 | K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) Convatec, GB | EZD |
| Nov 8, 2023 | K230400 | Cure Catheter Closed System; Cure Dextra Closed System Convatec, Inc. | EZD |
| Nov 17, 2022 | K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus Convatec, Inc. | EZD |
| Jun 22, 2022 | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter Convatec Limited, GB | GBM |
| Apr 30, 2019 | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) Convatec Limited, GB | KNT |
| Oct 19, 2018 | K180205 | AVELLE Negative Pressure Wound Therapy System Convatec Limited, GB | OMP |
| Aug 16, 2018 | K181206 | GentleCath Glide Intermittent Urinary Catheter Convatec Limited, GB | GBM |
| Jul 20, 2018 | K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber Convatec Limited, GB | FRO |
| Nov 21, 2017 | K172924 | GentleCath Intermittent Urinary Catheter Convatec Limited, GB | KOD |
| Mar 7, 2017 | K162906 | Flexi-Seal PROTECT Fecal Management System Convatec, GB | KNT |
| Sep 20, 2016 | K161344 | GentleCath Glide Intermittent Catheter Convatec Limited, GB | KOD |
| Jan 21, 2016 | K152926 | AQUACEL Ag Surgical SP Dressing Convatec Limited, GB | FRO |
| Jul 21, 2015 | K150350 | Flexi-Seal Signal Fecal Management System Convatec, Ltd., GB | KNT |
| Aug 1, 2014 | K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER Convatec, Ltd., GB | KOD |
| Jun 6, 2013 | K123481 | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE Convatec, Inc. | FRO |
| Jul 25, 2012 | K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER Convatec, Inc. | FRO |
| Apr 26, 2012 | K112342 | FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM Convatec, Inc. | KNT |
| Aug 19, 2011 | K111365 | VITALA CONTINENCE CONTROL DEVICE Convatec, Inc. | EZQ |
| Dec 1, 2010 | K102536 | VITALA CONTINENCE CONTROL DEVICE Convatec, Inc. | EZQ |
| Apr 2, 2010 | K083785 | VITALA CONTINENCE CONTROL DEVICE Convatec | EZQ |
| Dec 16, 2009 | K091034 | AQUACEL AG SURGICAL Convatec | FRO |
| Mar 7, 2008 | K071763 | AMADEUS ADAPTIVE COMPRESSION THERAPY Convatec | JOW |
| Dec 23, 1997 | K973689 | DUODERM HYDROACTIVE DRESSING Convatec, Ltd. | FRO |
| Dec 23, 1997 | K973688 | DUODERM CONTROL GEL FORMULA BORDER DRESSING Convatec, Ltd. | FRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2026 | ConvaTec, Inc Esteem Body Soft Convex Urostomy Pouch
Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 42 Open, Classified |
EXG | None listed |
| Jul 7, 2026 | ConvaTec, Inc Aquacel Ag Surgical SP
REF: 413556
9cm x 15cm/3.5 in. x 6 in., Sterile R Open, Classified |
FRO | K152926 |
| Mar 19, 2026 | ConvaTec, Inc Convatec, EsteemBody Drainable Pouch
REF:423657
10-35mm Open, Classified |
FON | None listed |
| Mar 19, 2026 | ConvaTec, Inc Convatec, EsteemBody Drainable Pouch
REF:423653
10-35mm Open, Classified |
FON | None listed |
| Mar 19, 2026 | ConvaTec, Inc Convatec, EsteemBody Drainable Pouch
REF:423643,
10-45mm Open, Classified |
FON | None listed |
| Oct 16, 2025 | ConvaTec, Inc DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas s Open, Classified |
NAD | None listed |
| Jan 10, 2025 | ConvaTec, Inc Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10) Open, Classified |
EXE | None listed |
| Sep 30, 2024 | ConvaTec, Inc ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile. Open, Classified |
FON | None listed |
| Apr 8, 2024 | ConvaTec, Inc ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit. Open, Classified |
NAC | None listed |
| Mar 21, 2024 | ConvaTec, Inc Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 4236 Open, Classified |
FON | None listed |
| Dec 19, 2022 | ConvaTec, Inc ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive Open, Classified |
FRO | K123481 |
| Oct 24, 2022 | ConvaTec, Inc ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure. Open, Classified |
EZQ | None listed |
| Oct 24, 2022 | ConvaTec, Inc ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure. Open, Classified |
EZQ | None listed |
| Oct 24, 2022 | ConvaTec, Inc ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975.
For the management of stoma output following a colostomy or ileostomy procedure. Open, Classified |
EZQ | None listed |
| Oct 24, 2022 | ConvaTec, Inc ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure. Open, Classified |
EZQ | None listed |
| Apr 22, 2022 | ConvaTec, Inc SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. Terminated |
EXE | None listed |
| Aug 20, 2021 | ConvaTec, Inc DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) Open, Classified |
NAD | None listed |
| Aug 9, 2021 | ConvaTec, Inc DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660)
DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957)
DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955) Open, Classified |
NAD | None listed |
| Sep 6, 2019 | ConvaTec, Inc Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands:
1) Combihesive Natura Durahesive
2) SurFit Natura Durahesive
3) Natura
4) Varicare
Product Usage: stoma management Terminated |
EXE | None listed |
| Jan 9, 2019 | ConvaTec, Inc FilterFlow Suction Handle CH24, 20 eaches per sales unit.
Product Usage:
Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for ort Open, Classified |
JOL | None listed |
| Jan 9, 2019 | ConvaTec, Inc Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM
Product Usage:
Urinary Catheters are sterile disposable devices intended to provide an in Open, Classified |
KOD | K896729 |
| Jan 9, 2019 | ConvaTec, Inc Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM
Product Usage:
Duodenal and Stomach Gastroenterology Tubes are sterile disposable de Open, Classified |
FPD | K896734 |
| Jan 9, 2019 | ConvaTec, Inc Forceps Blue, disposable, sterile, 100 eaches per sales unit.
Product Usage:
Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assis Open, Classified |
HTD | None listed |
| Jul 3, 2018 | ConvaTec, Inc AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301
AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring dev Terminated |
FEN | None listed |
| Apr 25, 2018 | ConvaTec, Inc Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475
Product Usage:
Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pou Terminated |
MMH | None listed |
| Oct 26, 2017 | ConvaTec, Inc SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802.
Intended for use as an ostomy protector providing a protective barrier to patient skin. Terminated |
PQE | None listed |
| May 24, 2017 | ConvaTec, Inc Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106 Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001 Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM Terminated |
BYG | None listed |
| May 24, 2017 | ConvaTec, Inc Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E; Terminated |
BYG | None listed |
| Mar 3, 2016 | ConvaTec, Inc Nebulizer Masks Opti-Mist and Opti-Mist Clear
Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient. Terminated |
LCQ | K801867 |
| Jun 13, 2014 | Convatec Inc. Convatec Flexi Seal Control Fecal Management System Rx Only
REF 411107
Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access Terminated |
KNT | None listed |
| Mar 20, 2014 | Convatec Inc. SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc
Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which Terminated |
KOD | None listed |
| Mar 20, 2014 | Convatec Inc. 'TORAY' Hydrocoat Foley Catheter
12 x10
4.00 mm Fr x mL
Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube whic Terminated |
KOD | None listed |
| Mar 20, 2014 | Convatec Inc. JMS, Japan, 3 WAY, 20 FR 10 mL
Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one majo Terminated |
KOD | None listed |
| Mar 20, 2014 | Convatec Inc. SLC 2-way standard Lubricious Coated
14ch/FR 5/10ml/cc
Product Usage: Usage:
Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tu Terminated |
KOD | None listed |
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