# K121360: Biodesign Ent Repair Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorprated
- Decided: Feb 27, 2013 after 296 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
Longest line of descent: 1 generation back to K002972 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002972: Merogel Control Gel Ent Surgical Dressing, Medtronic Xomed (2000) Summary page 1.

## Indications for use
The Biodesign® ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K121360
Methodology: https://510kreport.com/methodology