Spiration Valve System
FDA premarket approval P180007/S008 · decided 2021-09-01
Approval details
- PMA number
- P180007
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Spiration Valve System
- Generic name
- Valve, pulmonary
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2021-04-30
- Decision date
- 2021-09-01
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Approval for the Gyrus ACMI (Spiration) PAS Revisions to EMPROVE Study Protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |