FALOPE RING BAND AND APPLICATOR SYSTEMS
FDA premarket approval P870076/S022 · decided 2017-02-21
Approval details
- PMA number
- P870076
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FALOPE RING BAND AND APPLICATOR SYSTEMS
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2016-03-24
- Decision date
- 2017-02-21
- Days to decision
- 334 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Southborough, MA
- Statement
- Approval for a manufacturing site located at Ethox International, Inc., 2710 Northridge Drive NW Suite A, Grand Rapids, MI 49544-9112, as a packaging facility.
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| 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 |