# K181608: Disposable Standard Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics
- Decided: Sep 27, 2018 after 100 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: 3 generations back to K944467 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170379: Disposable Standard Clamp, Standard Bariatrics (2017) Summary page 4.

## Indications for use
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.

Source page: https://510kreport.com/device/K181608
Methodology: https://510kreport.com/methodology