LAPAROSCOPIC TROCAR
FDA 510(k) clearance K911483 · decided 1991-07-02
Clearance details
- K-number
- K911483
- Device name
- LAPAROSCOPIC TROCAR
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-04
- Decision date
- 1991-07-02
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DRC
- Device class
- 2
- Regulation number
- 870.1390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.