510(k) K926179
K926179 is an FDA 510(k) premarket notification submitted by Simpson/Basye, Inc. for the device "SEDLACEK HANDLE". The FDA issued a decision of Substantially Equivalent on March 25, 1994. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Simpson/Basye, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1994
- Date Received
- December 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocautery, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4120
- Review Panel
- OB
- Submission Type