Clearance Summary
SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 received FDA 510(k) clearance under submission number K901922, sponsored by Safte S.P.A.. 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 1990-10-26.
- Submission: K901922
- Applicant / Sponsor: Safte S.P.A.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5970
- Decision date: 1990-10-26
Classification & Regulation
This clearance is catalogued under FDA product code EXN and 21 CFR 876.5970, within the Gastroenterology, Urology review panel as a Class I device.