SELVERSTONE CLAMP SALIBI CLAMP
FDA 510(k) clearance K870399 · decided 1987-03-06
Clearance details
- K-number
- K870399
- Device name
- SELVERSTONE CLAMP SALIBI CLAMP
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-02
- Decision date
- 1987-03-06
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- HCE
- Device class
- 2
- Regulation number
- 882.5175
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Randolph, MA, 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 |
|---|---|---|
| CAROTID ARTERY CLAMP & TOOLS (K811821) | New England Surgical Instrument Corp. | 1981-09-24 |
Recalls involving this device
No recalls on record reference this clearance.