# K024286: Gyrus Open Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Nov 17, 2003 after 329 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932293 (1994). 9 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000496: Evershears Bipolar Scissors, Everest Medical Corp. (2000) Summary page 1.
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.
- K010010: Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure Generator, Valleylab, Inc. (2001) Summary page 1.

## Most influential descendants
- K081503: Aed Monopolar Lap Accessories (2008), 7 descendants of its own
- K103508: Unmiax Laparoscopic Instrument (2011), 6 descendants of its own
- K061975: Plasmaseal Open Forceps, Models 2103PK and 91701PK (2006), 4 descendants of its own
- K081766: PKS Omni Instrument (2008), 3 descendants of its own
- K161825: PK AIM (2016), 2 descendants of its own

## Recalls of this device
- Aug 18, 2009 · Not classified · Z-0632-2010: Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedur
- Aug 18, 2009 · Not classified · Z-0633-2010: Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedur
- Aug 18, 2009 · Not classified · Z-0634-2010: Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedur
- Aug 18, 2009 · Not classified · Z-0635-2010: Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedur
- Aug 18, 2009 · Not classified · Z-0637-2010: Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedur
- Aug 18, 2009 · Not classified · Z-0636-2010: Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedur

## Indications for use
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/K024286
Methodology: https://510kreport.com/methodology