# K050136: Reprocessed Hot Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jul 20, 2005 after 180 days
- Product code: NLU (Forceps, Biopsy, Electric, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860366 (1986). 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)
- K932790: Thermal Option, Cox Medical Ent., Inc. (1994) Summary page 1.
- K923470: Disposable Hot Biopsy Forceps, Wilson-Cook Medical, Inc. (1993) Summary page 1.
- K860366: Challenger Hot Biopsy Forceps, Microvasive (1986) Summary page 1.
- K905088: Hot Biopsy Forceps, Esco Precision, Inc. (1991) Summary page 1.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0560-2009: 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 Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.

Source page: https://510kreport.com/device/K050136
Methodology: https://510kreport.com/methodology