ENDOMED LAPAROSCOPY INSTRUMENTS
FDA 510(k) clearance K921686 · decided 1994-03-30
Clearance details
- K-number
- K921686
- Device name
- ENDOMED LAPAROSCOPY INSTRUMENTS
- Applicant
- Buckman Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-08
- Decision date
- 1994-03-30
- Days to decision
- 721 days
- Clearance type
- Traditional
- Product code
- KNF
- Device class
- 2
- Regulation number
- 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.