Proctoscope

FDA product code GCF · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K945209Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology InstrumentsGCF · Traditional KARL STORZ Endoscopy-America, Inc.03/06/1995SE
K790856Proctoscope #501GCF · Traditional C. Intl.05/29/1979SE

Recalls

RecallProductFirmInitiated
Z-0571-2024 Class IIInjection Needle, REF: 25207The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… Karl Storz Endoscopy10/24/2023Open, Classified