# K161000: Biodesign Otologic Repair Graft

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech Incorporated
- Decided: May 11, 2016 after 30 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: 2 generations back to K982870 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150594: Biodesign Otologic Repair Graft, Cook Biotech Incorprated (2015) Summary page 4.

## Most influential descendants
- K232646: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) (2024), 0 descendants of its own

## Indications for use
The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K161000
Methodology: https://510kreport.com/methodology