# K130669: Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Olsen Medical
- Decided: Dec 6, 2013 after 269 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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: 7 generations back to K923332 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884656: Disposable Bipolar Cord and Bipolar Forcep, Dermacare (1988) Summary page 1.
- K982705: Midas Touch Bipolar Forceps, Iti Medical Technologies, Inc. (1998) Summary page 1.
- K093108: Stryker Bipolar Forceps, Stryker Leibinger GmbH & Co KG (2010) Summary page 1.
- K950877: Reusable Monopolar Forceps, Boston Surgical Products, Inc. (1995) Summary page 2.

## Most influential descendants
- K210315: Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps (2022), 0 descendants of its own

## Recalls of this device
- May 11, 2018 · Class II · Z-1944-2018: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

## Indications for use
The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.

Source page: https://510kreport.com/device/K130669
Methodology: https://510kreport.com/methodology