INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
FDA 510(k) clearance K934338 · decided 1994-02-10
Clearance details
- K-number
- K934338
- Device name
- INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
- Applicant
- Innovasive Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-07
- Decision date
- 1994-02-10
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hopkinton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.