# K980177: Sugitron Model: Iec

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: Jul 7, 1998 after 168 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.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices 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

## Most influential descendants
- K992382: Surgitron Radiolase (1999), 7 descendants of its own
- K014216: Secca System (2002), 5 descendants of its own
- K110143: Het Bipolar Electrocautery Forceps (2011), 3 descendants of its own
- K121085: Het Bipolar Ligator System (2012), 2 descendants of its own
- K140422: Het Systems, LLC, Het Bipolar Ligator System (2014), 1 descendant of its own

## Indications for use
is idendical to the Surgitron as a preammendment device such as: * Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures. * Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Neévi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic 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/K980177
Methodology: https://510kreport.com/methodology