Clearance Summary
GS-4350 TROCAR ONLY, 5.5MM received FDA 510(k) clearance under submission number K900963, sponsored by Solos Endoscopy, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-04-18.
- Submission: K900963
- Applicant / Sponsor: Solos Endoscopy, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5090
- Decision date: 1990-04-18
Classification & Regulation
This clearance is catalogued under FDA product code FBM and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class I device.