# K042648: Reprocessed Cold Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jul 20, 2005 after 295 days
- Product code: NON (Forceps, Biopsy, Non-Electric, Reprocessed)
- Device class: 1
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Precisor EXL Cold biopsy Forceps: named in the summary without a submission number
- (no number) Radial Jaw 3 Cold biopsy forceps: named in the summary without a submission number

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0575-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. These forceps are advanced to the site for sampling via the operating channel of an endoscope.

Source page: https://510kreport.com/device/K042648
Methodology: https://510kreport.com/methodology