FMS ARTHRO-CUTTER
FDA 510(k) clearance K951701 · decided 1995-05-09
Clearance details
- K-number
- K951701
- Device name
- FMS ARTHRO-CUTTER
- Applicant
- Future Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-12
- Decision date
- 1995-05-09
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- HNX
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- New York City, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FMS HIGH FLOW ARTHRO-SHEATH (K951702) | Future Medical Systems, Inc. | 1995-05-12 |
Recalls involving this device
No recalls on record reference this clearance.