Data / Medical devices / India / Hollister Medical India Private Limited
Hollister Medical India Private Limited: FDA-registered device maker in Bawal, Rewari Haryana, India, 4 510(k) clearances
Hollister Medical India Private Limited is registered with the FDA (registration 3008191244) in Bawal, Rewari Haryana, India. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 9, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008191244
- Address
- Plot No. 27, Sector 5 Phase II, HSIIDC Growth Center, Bawal, Rewari Haryana, India, 123501
- Owner or operator
- Hollister Inc. (1480288)
- Roles
- Manufacturer
- First device listed
- July 21, 1992
- Registered through
- 2026
- Brand names listed
- Adapt, Advance (KOD), Advance Plus (KOD), Advance Plus Kit, Advance Plus Pocket (KOD), Apogee, Apogee IC, Apogee Plus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter Care Tray | OHR | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Urethral | GBM | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Manufacturer | accessdata.fda.gov |
| Collector, Ostomy | EXB | 1 | Manufacturer | accessdata.fda.gov |
| Irrigator, Ostomy | EXD | 2 | Manufacturer | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | 1 | Manufacturer | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2004 | K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | KOD | Substantially Equivalent | Apogee Medical, Inc. | accessdata.fda.gov |
| January 14, 2002 | K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | KOD | Substantially Equivalent | Hollister, Inc. | accessdata.fda.gov |
| July 18, 2001 | K011552 | UROLOGICAL CATHETER | GBM | Substantially Equivalent | Apogee Medical, Inc. | accessdata.fda.gov |
| September 3, 1999 | K992137 | UROLOGICAL CATHETER | GBM | Substantially Equivalent | Apogee, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
- All makers of Catheter, Urethral
- All makers of Catheter Care Tray
- All makers of Collector, Ostomy
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
- All makers of Catheter, Urological
Updated January 9, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.