AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP
FDA 510(k) clearance K914753 · decided 1992-06-11
Clearance details
- K-number
- K914753
- Device name
- AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1991-10-22
- Decision date
- 1992-06-11
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- GET
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.