# K153358: Standard Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics
- Decided: May 2, 2016 after 164 days
- Product code: GDJ (Clamp, Surgical, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Doyen Atraumatic Bowel Clamp: named in the summary without a submission number

## Most influential descendants
- K161720: Standard Clamp (2016), 2 descendants of its own
- K170379: Disposable Standard Clamp (2017), 1 descendant of its own
- K181608: Disposable Standard Clamp (2018), 0 descendants of its own

## Indications for use
The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.

Source page: https://510kreport.com/device/K153358
Methodology: https://510kreport.com/methodology