FILSHIE CLIP(MARK VI) SYSTEM
FDA premarket approval P920046/S008 · decided 2016-12-02
Approval details
- PMA number
- P920046
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FILSHIE CLIP(MARK VI) SYSTEM
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Femcare , Ltd.
- Date received
- 2014-06-09
- Decision date
- 2016-12-02
- Days to decision
- 907 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Romsey
- Statement
- Approval for the single use only Sterishot II Applicator.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LI VASECTOMY (K932465) | Femcare , Ltd. | 1994-03-02 |
| ADD-A-CATH (K884061) | Femcare , Ltd. | 1988-10-25 |