# K100442: Fastclamp Endoscopic Clamping System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Innovations Group Plc
- Decided: Sep 7, 2010 after 202 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945572 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092684: Laparoscopic Retractors, Cardinal Health, Inc. (2010) Summary page 1.
- K070509: Fisso Holding System, Baitella AG (2007) Summary page 1.
- (no number) Mediflex Flex Arm Systems - Mediflex surgical products: named in the summary without a submission number
- (no number) Thompson Retractor - Thompson Surgical Instruments, Inc.: named in the summary without a submission number

## Indications for use
Use in laparoscopic procedures for the surgeon to clamp endloscopic instruments in a fixed position for a period of time.

Source page: https://510kreport.com/device/K100442
Methodology: https://510kreport.com/methodology