FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
FDA premarket approval P870076/S001 · decided 1996-01-02
Approval details
- PMA number
- P870076
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 1995-09-01
- Decision date
- 1996-01-02
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Southborough, MA
- Statement
- APPROVAL FOR A CHANGE OF STERILIZATION FACILITY TO THE GRIFFITH MICROSCIENCE FACILITY IN WILLOWBROOK, ILLINOIS, FOR THE PRODUCTS INCLUDING THE DISPOSABLE FALOPE-RING APPLICATOR KIT WITH 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 005280-901), AND DISPOSABLE FALOPE-RING APPLICATOR KIT WITHOUT 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 006889-901)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (K252487) | Gyrus Acmi, Inc. | 2026-03-02 |
| RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) (K233275) | Gyrus Acmi, Inc. | 2024-03-25 |
| POWERSEAL Sealer and Divider (K231327) | Gyrus Acmi, Inc. | 2023-10-25 |
| SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (K221306) | Gyrus Acmi, Inc. | 2023-01-27 |
| Celeris, Disposable Sinus Debrider (K212650) | Gyrus Acmi, Inc. | 2022-01-19 |
| Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (K213831) | Gyrus Acmi, Inc. | 2022-01-04 |
| SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K211401) | Gyrus Acmi, Inc. | 2021-06-03 |
| ChitoZolve (K181696) | Gyrus Acmi, Inc. | 2018-11-30 |