# K971202: Comeg Optical Stone Crushing Forceps, Comeg Visual Obturators for Urology, Comeg Optical Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Comeg Endoskopie GmbH
- Decided: May 27, 1997 after 56 days
- Product code: OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- 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 its predicate without a number.
- (no number) Karl Storz Short Jaw Biopsy Forceps: named in the summary without a submission number
- (no number) Visual Obturators for Cystoscopes - Urethroscopes: named in the summary without a submission number
- (no number) Kidney Stone Crusher: named in the summary without a submission number

## Indications for use
Optical Biopsy Forceps - The intended use is in urological procedures to endoscopically remove tissue for evaluation. Urological Visual Obturators - The intended use is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The obturator is inserted into the sheath and its blunt end protrudes from the distal end. It protects the tissue when the sheath is entered into the area under examination. The visual obturator has a cystoscope directly inserted in the center of the obturators to allow for visualization while entering the subject. Optical Stone Crushing Forceps - The intended use for the optical stone crushing forceps is in urological procedures to endoscopically remove, manipulate, crush, or grasp calculi (i.e. stones) and other foreign objects.

Source page: https://510kreport.com/device/K971202
Methodology: https://510kreport.com/methodology