Company ยท US
Hollister, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2026. Name variants (Inc, Corp, punctuation) are merged.
100510(k) clearances (1 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EXB | Collector, Ostomy | 14 |
| GBM | Catheter, Urethral | 11 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 10 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 8 |
| ILO | Pack, Hot Or Cold, Water Circulating | 7 |
| FRO | Dressing, Wound, Drug | 6 |
| EZD | Catheter, Straight | 5 |
| CBH | Device, Fixation, Tracheal Tube | 4 |
| FMQ | Restraint, Protective | 4 |
| HIR | Perineometer | 4 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 4 |
| EXI | Device, Paste-On For Incontinence, Sterile | 2 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 2 |
| FMZ | Incubator, Neonatal | 2 |
| HDB | Extractor, Vacuum, Fetal | 2 |
| HFW | Clamp, Umbilical | 2 |
| HGY | Pump, Breast, Non-Powered | 2 |
| KOD | Catheter, Urological | 2 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 2 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2026 | K253295 | Coude Sleeved IC; Coude Plus Sleeved IC Hollister Incorporated | EZD |
| Oct 3, 2025 | K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (na Hollister Incorporated | EZD |
| May 3, 2024 | K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket Hollister Incorporated | EZD |
| Dec 8, 2022 | K220667 | Sleeved IC Hollister Incorporated | EZD |
| Sep 13, 2022 | K213575 | Female IC (Not Finalized) Hollister Incorporated | EZD |
| Jan 27, 2022 | K211436 | Intermittent Catheter (Not Finalized) Hollister Incorporated | GBM |
| Dec 13, 2019 | K193148 | VaPro Plus Pocket, VaPro Plus Hollister Incorporated | GBM |
| Jul 19, 2019 | K191633 | Infyna Chic Hollister Incorporated | GBM |
| Dec 18, 2018 | K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket Hollister Incorporated | GBM |
| Jun 22, 2018 | K180824 | VaPro 2 Intermittent Catheter Hollister Incorporated | GBM |
| Jan 26, 2017 | K163179 | Onli Intermittent Catheter Hollister Incorporated | GBM |
| Sep 9, 2015 | K152268 | VAPRO PLUS POCKET Intermittent Catheter Hollister Incorporated | GBM |
| Jan 9, 2015 | K143594 | VaPro Pocket Hollister Incorporated | GBM |
| Aug 22, 2014 | K141642 | VAPRO INTERMITTENT CATHETER Hollister Incorporated | GBM |
| Apr 17, 2013 | K123804 | INSTAFLO BOWEL CATHETER SYSTEM KIT Hollister, Inc. | KNT |
| Apr 26, 2011 | K110862 | VAPRO PLUS INTERMITTENT CATHETER Hollister Incorporated | GBM |
| Apr 22, 2010 | K100273 | INSTAFLO BOWEL CATHETER SYSTEM KIT Hollister, Inc. | KNT |
| Aug 20, 2009 | K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, Hollister, Inc. | GBM |
| Feb 4, 2009 | K083153 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 Hollister, Inc. | KNT |
| Apr 12, 2005 | K050483 | EVADRI BLADDER CONTROL SYSTEMS Hollister, Inc. | KPI |
| May 17, 2004 | K040779 | RESTORE WOUND CLEANSER Hollister, Inc. | KMF |
| Mar 19, 2002 | K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM Hollister, Inc. | HIR |
| Mar 5, 2002 | K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE Hollister, Inc. | HIR |
| Jan 14, 2002 | K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT Hollister, Inc. | KOD |
| Jan 7, 2002 | K013345 | INCARE INTERMITTENT CATHETER Hollister, Inc. | KOD |
| Dec 19, 2001 | K013141 | MICROGYN PLUS STIMULATION DEVICE Hollister, Inc. | KPI |
| Aug 15, 2001 | K011519 | AMEDA HYGIENIKIT Hollister, Inc. | HGY |
| Oct 14, 1999 | K991214 | SIMPLICARE TRANSPARENT WOUND DRESSING Hollister, Inc. | MGP |
| Mar 25, 1999 | K990456 | ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP Hollister, Inc. | KPI |
| Aug 21, 1998 | K980976 | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP Hollister, Inc. | HDB |
| Feb 20, 1998 | K980209 | SIMPLICARE THIN FILM WOUND DRESSINGS Hollister, Inc. | MGP |
| Dec 23, 1997 | K974048 | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER Hollister, Inc. | KPI |
| Nov 3, 1997 | K973023 | INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET Hollister, Inc. | ILO |
| Jun 25, 1997 | K971541 | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON Hollister, Inc. | KPI |
| Apr 15, 1997 | K970602 | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL Hollister, Inc. | KPI |
| Feb 25, 1997 | K970443 | HOLLISTER RETRACTED PENIS POUCH Hollister, Inc. | EXI |
| Dec 31, 1996 | K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET Hollister, Inc. | ILO |
| Dec 31, 1996 | K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) Hollister, Inc. | ILO |
| Nov 27, 1996 | K962537 | INCARE HOT/ICE LITE MACHINE Hollister, Inc. | ILO |
| Nov 1, 1996 | K963199 | HEELBO PELVIC RESTRAINT Hollister, Inc. | FMQ |
| Oct 24, 1996 | K962964 | HEELBO JOHNNY GRAIT BELT SECURITY BELT Hollister, Inc. | FMQ |
| Oct 24, 1996 | K962963 | CHECKMATE ANKLE RESTRAINT SYSTEM Hollister, Inc. | FMQ |
| Oct 23, 1996 | K963222 | MICROGYN PLUS STIMULATION DEVICE Hollister, Inc. | KPI |
| Oct 9, 1996 | K963108 | HEELBO QUILTED TORSO RESTRAINT Hollister, Inc. | FMQ |
| Sep 16, 1996 | K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER Hollister, Inc. | EXJ |
| Aug 9, 1996 | K961872 | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER Hollister, Inc. | KPI |
| Apr 18, 1996 | K960311 | PERINEOMETER Hollister, Inc. | HIR |
| Oct 23, 1995 | K954621 | RECLOSABLE WOUND COVER Hollister, Inc. | FRO |
| Oct 17, 1995 | K930530 | INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC Hollister, Inc. | KPI |
| Oct 6, 1995 | K954235 | HOLLISTER HYDROCOLLOID WOUND DRESSING Hollister, Inc. | FRO |
Newest 50 of 100.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2025 | Hollister Incorporated AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800, Open, Classified |
CBH | None listed |
| Feb 19, 2025 | Hollister Incorporated AnchorFast, Oral Endotracheal Tube Fastener, REF 9799, Open, Classified |
CBH | None listed |
| Feb 19, 2025 | Hollister Incorporated AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787, Open, Classified |
CBH | None listed |
| Feb 19, 2025 | Hollister Incorporated AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700, Open, Classified |
CBH | None listed |
| Feb 11, 2021 | Hollister Incorporated Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-4 Terminated |
KNT | K932855 |