Sinuscope
510(k) K944186
Sinuscope is a Class II device made by Stryker Endoscopy, cleared under FDA 510(k) K944186 on 7 Nov 1994, active as of 26 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944186 | Date7 Nov 1994 | StatusActive |
Official records
- FDA 510(k) database K944186
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EOB
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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- Ambu aScope RLS Slim by Ambu A/S
- 8700H by Karl Storz SE & CO. KG
- Olympus WA96206A by Olympus Winter & Ibe GmbH
- 11101HD by Karl Storz SE & CO. KG
- TRANSTYMPANIC ENDOSCOPE by Endooptiks, Inc.