Spiration Valve System (SVS)
FDA premarket approval P180007/S015 · decided 2026-05-07
Approval details
- PMA number
- P180007
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spiration Valve System (SVS)
- Generic name
- Valve, pulmonary
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2026-04-15
- Decision date
- 2026-05-07
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- The firm is submitting this 30-Day Notice of a change in the verification and validation process of the Water Treatment System. The firm is adding endotoxin testing for the water samples and related process modifications to the manufacturing work instruction.
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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 |