# K142525: PK Lap Loop

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Nov 21, 2014 after 74 days
- Product code: HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K936109 (1994). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122605: PKS Bill, Gyrus Acmi, Inc. (2012) Summary page 6.
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill), Gyrus Acmi, Inc. (2011) Summary page 9.

## Indications for use
The Bipolar Laparoscopic Loop PK Lap Loop is a Smm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Olympus Electrosurgical Generator ESG-400.

Source page: https://510kreport.com/device/K142525
Methodology: https://510kreport.com/methodology