NON-SHIELDED SURGICAL TROCAR AND SLEEVE
FDA 510(k) clearance K963760 · decided 1997-01-08
Clearance details
- K-number
- K963760
- Device name
- NON-SHIELDED SURGICAL TROCAR AND SLEEVE
- Applicant
- Ethicon Endo-Surgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-18
- Decision date
- 1997-01-08
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.