# K061975: Plasmaseal Open Forceps, Models 2103PK and 91701PK

- Pathway: 510(k) (Special)
- Applicant: Acmi Corporation
- Decided: Aug 10, 2006 after 28 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: 3 generations back to K932293 (1994). 10 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024286: Gyrus Open Forceps, Gyrus Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K081766: PKS Omni Instrument (2008), 3 descendants of its own
- K161825: PK AIM (2016), 2 descendants of its own
- K163373: PK AIM (2016), 1 descendant of its own
- K170908: PK AIM (2017), 0 descendants of its own

## Indications for use
The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

Source page: https://510kreport.com/device/K061975
Methodology: https://510kreport.com/methodology