Data / Medical devices / United Kingdom / Femcare Ltd.
Femcare Ltd.: FDA-registered device maker in ROMSEY Hampshire, United Kingdom, 1 510(k) clearance and 1 PMA approval
Femcare Ltd. is registered with the FDA (registration 8021955) in ROMSEY Hampshire, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated September 5, 1996. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8021955
- FEI number
- 3002806976
- Address
- 32 Premier Way, ROMSEY Hampshire, United Kingdom, SO51 9DQ
- Owner or operator
- FEMCARE LTD. (8021955)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 21, 1994
- Registered through
- 2027
- Brand names listed
- Filshie Tubal Ligation System, Non-scalpel vasectomy instrument, Supra Foley Catheter Introducer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Suprapubic (And Accessories) | KOB | 2 | Specification developer | accessdata.fda.gov |
| Laparoscopic Contraceptive Tubal Occlusion Device | KNH | 3 | Manufacturer | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | 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 |
|---|---|---|---|---|---|---|
| October 25, 1988 | K884061 | ADD-A-CATH | KOB | Substantially Equivalent | Femcare , Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 5, 1996 | P920046 | FILSHIE CLIP (MARK VI) SYSTEM | KNH | 11 | December 3, 2024 | accessdata.fda.gov |
Compare with other makers
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
- All makers of Catheter, Suprapubic (And Accessories)
- All makers of Laparoscopic Contraceptive Tubal Occlusion Device
Updated December 3, 2024. 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.