# K232646: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: May 24, 2024 after 268 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982870 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161000: Biodesign Otologic Repair Graft, Cook Biotech Incorporated (2016) Summary page 4.

## Recalls of this device
- Nov 22, 2024 · Class II · Z-0832-2025: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

## Indications for use
The Biodesign Otologic Butterfly Graft is intended for use as an implant material to aid in the natural healing process in myringloplasty and tympanoplasty procedures.

Source page: https://510kreport.com/device/K232646
Methodology: https://510kreport.com/methodology