# K152531: InstaClear Lens Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jan 15, 2016 after 134 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902683 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982594: Endo-Scrub/Endo-Scrub 2, Xomed, Inc. (1998) Summary page 5.

## Recalls of this device
- Apr 3, 2024 · Class II · Z-1888-2024: Potential for distal end of the sheath to break off during a procedure.
- Jan 16, 2024 · Class II · Z-1368-2024: Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Jap

## Indications for use
Intended to clear the end of a rigid rod endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.

Source page: https://510kreport.com/device/K152531
Methodology: https://510kreport.com/methodology