Panels › Gastroenterology, Urology › Product code KOD · Class 2
Catheter, Urological
Regulation 876.5130
1510(k)s in 12 months (238 all time)
1recalls in 12 months (108 all time)
80recalls that name a 510(k)
Top companies in KOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Nurse Assist, Inc | 0 | 34 |
| C.R. Bard, Inc. | 10 | 12 |
| COVIDIEN LLC | 0 | 17 |
| Teleflex Medical | 0 | 17 |
| Rochester Medical Corp. | 2 | 14 |
| Convatec Limited | 3 | 7 |
| Abco Dealers, Inc. | 9 | 0 |
| Van-Tec, Inc. | 8 | 0 |
| Boston Scientific Corp | 5 | 2 |
| The Kendal Co. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep Intermittent Catheter Tray
REF:
INTP16
INTS14
INTS14C
INTS16
INTS16C
PEDINTS06
PEDINTS08
PEDINTS10
UDI code:
00801741183300 10801741183307
008017411 Open, Classified |
KOD | K000723 K802665 |
| Jul 3, 2025 | C.R. Bard Inc BD Heyman Follower Coude Tip for following sizes:
12Fr - REF:021312
14Fr - REF:021314,
16Fr - REF: 021316 Open, Classified |
KOD | None listed |
| Jul 3, 2025 | C.R. Bard Inc BD Heyman Follower Straight Tip for following sizes:
10Fr - REF:21110,
12Fr - REF:21112,
14Fr - REF: 21114,
20Fr - REF: 21120 Open, Classified |
KOD | None listed |
| Feb 16, 2024 | Cardinal Health 200, LLC Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE Open, Classified |
KOD | K860484 |
| Nov 11, 2022 | TELEFLEX LLC Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter. Open, Classified |
KOD | K010420 |
| Jan 27, 2022 | C.R. Bard Inc BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C Terminated |
KOD | K000723 |
| Jan 27, 2022 | C.R. Bard Inc BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C Terminated |
KOD | K000723 |
| Jan 11, 2021 | C.R. Bard, Inc. Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only. Terminated |
KOD | K802665 |
| Apr 30, 2020 | Covidien Llc Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, T Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Sec Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Secu Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring Terminated |
KOD | K933400 |
| Apr 30, 2020 | Covidien Llc Dover 100% Silicone Foley Catheter with Temperature Sensor
14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescriptio Terminated |
KOD | K933400 |
| Jul 1, 2019 | Teleflex Medical Rusch EasyCath Kit Terminated |
KOD | K000070 |
| 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 |
| Jul 11, 2018 | COVIDIEN LLC P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS Terminated |
KOD | K933400 |
| Jul 11, 2018 | COVIDIEN LLC P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS Terminated |
KOD | K933400 |
| Jul 11, 2018 | COVIDIEN LLC 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD Terminated |
KOD | K933400 |
| Jul 11, 2018 | COVIDIEN LLC 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD Terminated |
KOD | K933400 |
| Jul 11, 2018 | COVIDIEN LLC TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T Terminated |
KOD | K933400 |
| Jul 11, 2018 | COVIDIEN LLC 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD Terminated |
KOD | K933400 |
| Nov 22, 2016 | Teleflex Medical RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile,
Intermittent self-catheterization Terminated |
KOD | K010420 |
| Sep 3, 2015 | C.R. Bard, Inc. Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box.
Used as an Intermitt Terminated |
KOD | K000723 |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S.
Intermittent catheter. Terminated |
KOD | K000723 |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616.
Intermittent catheter. Terminated |
KOD | K000723 |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614.
Intermittent catheter. Terminated |
KOD | K000723 |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612.
Intermittent catheter. Terminated |
KOD | K000723 |
| Aug 14, 2015 | C.R. Bard, Inc. Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610.
Intermittent catheter. Terminated |
KOD | K000723 |
| Sep 18, 2014 | Teleflex Medical Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile.
These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or des Terminated |
KOD | None listed |
| Jun 9, 2014 | Teleflex Medical RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708.
A tubular device that is inserted through the urethera and is used to pass flui Terminated |
KOD | K000070 |
| 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 |
| Mar 20, 2014 | Convatec Inc. Curion CuriStay Nelaton
CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL
Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated Terminated |
KOD | None listed |
| Mar 20, 2014 | Convatec Inc. Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces
model number DNYD11914
Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous c Terminated |
KOD | None listed |
| Oct 4, 2012 | C.R. Bard, Inc., Urological Division 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used Terminated |
KOD | K821745 |
| Apr 11, 2012 | Boston Scientific Corporation Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760 Terminated |
KOD | K011965 K102527 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Mi Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com
CATHETER CARE KIT Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7402 (STERILE) URETHRAL CATHETER KIT (Female) 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com
URETHRAL Terminated |
KOD | K830359 |
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