# K061307: Bovie Inaflash Suture Remover Handle,Charger,Handle and Charger,Kit,Battery Pack

- Pathway: 510(k) (Traditional)
- Applicant: Aaron Medical Industries
- Decided: Jul 18, 2006 after 69 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K840434 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840434: Replace-a-Tip Low Temp. Cautery, Suncoast Medical Manufacturers, Inc. (1984) Summary page 2.
- K841591: Pyro-Tip, Suncoast Medical Manufacturers, Inc. (1984) Summary page 2.
- K023506: Surgical Medical Device Cautery, Modern Medical Equipment Mfg., Ltd. (2004) Summary page 2.
- (no number) Suture Removal Kit: named in the summary without a submission number
- (no number) Battery Pack: named in the summary without a submission number
- (no number) Gauze: named in the summary without a submission number
- (no number) Forceps: named in the summary without a submission number

## Indications for use
The Bovie Suture Remover is used to perform suture removal procedures in health care facilities and veterinary offices. The suture removal procedures include those in which the sutures are located externally on the surface of the skin.

Source page: https://510kreport.com/device/K061307
Methodology: https://510kreport.com/methodology