Clearance Summary
KARL STORZ BOUGIES AND DILATORS received FDA 510(k) clearance under submission number K950125, sponsored by KARL STORZ Endoscopy-America, 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 1995-02-07.
- Submission: K950125
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5520
- Decision date: 1995-02-07
Classification & Regulation
This clearance is catalogued under FDA product code FAX and 21 CFR 876.5520, within the Gastroenterology, Urology review panel as a Class I device.