510(k) K900965
K900965 is an FDA 510(k) premarket notification submitted by Solos Endoscopy, Inc. for the device "GS-4550 TROCAR ONLY, 11MM". The FDA issued a decision of Substantially Equivalent on April 18, 1990. The device falls under product code FBM (Cannula And Trocar, Suprapubic, Non-Disposable), a Class I device regulated under 21 CFR 876.5090. Solos Endoscopy, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1990
- Date Received
- February 27, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula And Trocar, Suprapubic, Non-Disposable
- Device Class
- Class I
- Regulation Number
- 876.5090
- Review Panel
- GU
- Submission Type