LI VASECTOMY
FDA 510(k) clearance K932465 · decided 1994-03-02
Clearance details
- K-number
- K932465
- Device name
- LI VASECTOMY
- Applicant
- Femcare , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-21
- Decision date
- 1994-03-02
- Days to decision
- 285 days
- Clearance type
- Traditional
- Product code
- KOA
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ng7 3en England, GB
- Third-party review
- No
- Expedited review
- No
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| BENDEREV PROTECT-A-PASS NEEDLE (K921228) | Eimark Labs, Inc. | 1992-09-14 |
| VAS DILATOR (K922192) | Cook Urological, Inc. | 1992-08-07 |
| GRASPING FORCEPS (K896058) | Annex Medical, Inc. | 1989-12-28 |
| MARLOW ANAL SPECULUM (K891352) | Simpson/Basye, Inc. | 1989-06-23 |
| MICROSURGICAL CYSTOTOME (K890218) | Kinetic Medical Products | 1989-01-27 |
| STOMACH EVACULATOR - EWALD STYLE (K864963) | Medovations, Inc. | 1987-10-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Filshie Clip (Mark VI) System (P920046/S015) | Femcare , Ltd. | 2024-12-03 |
| Filshie Clip (Mark VI) System (P920046/S014) | Femcare , Ltd. | 2024-09-16 |
| Filshie Clip System (P920046/S013) | Femcare , Ltd. | 2023-12-18 |
| Filshie Clip (Mark VI) System (P920046/S012) | Femcare , Ltd. | 2022-01-06 |
| Filshie Clip (Mark VI) System (P920046/S011) | Femcare , Ltd. | 2019-10-09 |
| Sterishot II Mini Flishie Clip Applicator (P920046/S010) | Femcare , Ltd. | 2017-05-26 |
| FILSHIE CLIP(MARK VI) SYSTEM (P920046/S008) | Femcare , Ltd. | 2016-12-02 |
| FILSHIE CLIP (MARK VI) SYSTEM (P920046/S009) | Femcare , Ltd. | 2016-09-09 |