VERSAPOINT RESECTOSCOPIC SYSTEM
FDA 510(k) clearance K040302 · decided 2004-03-09
Clearance details
- K-number
- K040302
- Device name
- VERSAPOINT RESECTOSCOPIC SYSTEM
- Applicant
- Gynecare, A Div. of Ethicon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-09
- Decision date
- 2004-03-09
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.