# K970764: Comeg Endoscopy Resectoscope Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Comeg Endoscopy
- Decided: Apr 22, 1997 after 50 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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 resectoscope accessories: named in the summary without a submission number
- (no number) Circon ACMI Sheaths: named in the summary without a submission number
- (no number) Circon ACMI inner and outer sheaths: named in the summary without a submission number

## Indications for use
Continuous-Flow Inner and Outer Sheaths The intended use for the continuous-flow inner and outer sheaths is in urological procedures to endoscopically examine and allow access to the urethra and bladder and also provide simultaneous suction and irrigation for the resectoscope. The surgeon performs the procedure through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes, resectoscopes, and various instrumentation. 2 Fixed Stopcock and 2-Way-Tap Outer Sheaths The intended use for these devices is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The surgeon performs the examination through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes and various instruments and also allow for simultaneous suction and irrigation. Obturators: The intended use for the obturators 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. Cystoscope Diagnostic Adapters The intended use for the cysotocope diagnostic adapter is in urological procedures to bridge the cystoscope to the cystoscope sheath. In versions with operating channels, it also provides passage for instruments. Dilator, Urethral Meatus: The intended use for the dilator is in urological procedures. It is inserted into the urethra and is intended to dilate the penis for insertion of a catheter or instrumentation. Urological Syringe and Evacuator with Adapter The intended use for the urological syringe and evacuator with adapter is in urological procedures. The syringe is connected directly to the sheath and is used for manual suction and irrigation of the bladder. The evacuator is used to remove loose debris (tissue) from the bladder. It is also connected directly to the sheath. Single Action scissors The intended use for the single action scissors is in urological and gastroenterological procedures to endoscopically cut tissue and/or sutures. Luer Lock Connectors. The intended use for the luer lock connectors is in urological procedures. The luer is connected directly to the sheath suction and irrigation port and is used to connect catheters and suction and irrigation tubes to sheaths. They provide an adaption, extension, or stopcock.

Source page: https://510kreport.com/device/K970764
Methodology: https://510kreport.com/methodology