# K972072: Surgitron Model FFPF-Emc

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: Jun 19, 1997 after 16 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
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.
- (no number) Surgitron: named in the summary without a submission number

## Indications for use
Indication For Use is identical to the Surgitron as a preamendment device such as: * Cutting Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection. * Blended Cutting and Coagulation Skin Tags. Papilloma Keloids, Keratosis, Verrucas, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures. * Hemostasis Control of Bleeding, Epilation, Telangiectasia * Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis. * Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

Source page: https://510kreport.com/device/K972072
Methodology: https://510kreport.com/methodology