Clearance Summary
MARLOW ANAL SPECULUM received FDA 510(k) clearance under submission number K891352, sponsored by Simpson/Basye, 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 1989-06-23.
- Submission: K891352
- Applicant / Sponsor: Simpson/Basye, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1989-06-23
Classification & Regulation
This clearance is catalogued under FDA product code KOA and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.