# K051700: Opticlean Lens Irrigator & Optidock Tissue Ligator

- Pathway: 510(k) (Traditional)
- Applicant: Medchannel, LLC
- Decided: Aug 15, 2005 after 52 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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) Endoscopic Anti Fog Device: named in the summary without a submission number
- (no number) Endoscopic Irrigation Channel: named in the summary without a submission number
- (no number) Endosuture Suture Passer: named in the summary without a submission number
- (no number) Surgisorb Absorbable Suture: named in the summary without a submission number

## Indications for use
The OptiCLEAN Lens Irrigator is a disposable device to be used in combination with a 10 mm diameter scope to prevent dimming and fogging of the lens. The OptiDOCK Tissue Ligator is a disposable device intended to pass an absorbable suture loop during endoscopic procedures.

Source page: https://510kreport.com/device/K051700
Methodology: https://510kreport.com/methodology