# K945209: Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology Instruments

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Mar 6, 1995 after 132 days
- Product code: GCF (Proctoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Oct 24, 2023 · Class II · Z-0571-2024: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher ri

## Indications for use
The Karl Storz Endoscopy Proctoscopes, Sigmoidoscopes, Accessories, and Proctosigmoidoscopy Instruments are manually operated, reusable devices which are designed for use by qualified surgeons during gastroenterological endoscopic procedures.

Source page: https://510kreport.com/device/K945209
Methodology: https://510kreport.com/methodology