# K060561: Clearadex Gel

- Pathway: 510(k) (Traditional)
- Applicant: Cambridgemed
- Decided: May 30, 2006 after 88 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CLEARADEX GEL is a space-occupying gel is intended for use by a medical professional: to control minimal bleeding following ENT surgery to separate and prevent adhesions between mucosal surfaces in the nasal cavity as an adjunct to aid in the natural healing process during the postoperative period

Source page: https://510kreport.com/device/K060561
Methodology: https://510kreport.com/methodology