DISPOSABLE FALOPE-RING BANK APPLICATOR KITS
FDA premarket approval P870076/S020 · decided 2016-02-09
Approval details
- PMA number
- P870076
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DISPOSABLE FALOPE-RING BANK APPLICATOR KITS
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2016-01-13
- Decision date
- 2016-02-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Southborough, MA
- Statement
- Change in suppliers from Senior Operations LLC (formerly known as GA MFG Precision) to C&M Machine for the manufacture of the following components of the subject device: 1) Locating Pin (part number 005267); and 2) Vercap Insert Seal Base (part number 005137).
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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 |