# K970083: Dynabite Hot GI Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Portlyn Corp.
- Decided: Jun 17, 1997 after 159 days
- Product code: KGE (Forceps, Biopsy, Electric)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) MicroVasive Hot Biopsy Forceps: named in the summary without a submission number
- (no number) Hot Biopsy Forceps: named in the summary without a submission number
- (no number) DynaBite GI Biopsy Forceps (non-electric): named in the summary without a submission number

## Most influential descendants
- K014216: Secca System (2002), 5 descendants of its own
- K110143: Het Bipolar Electrocautery Forceps (2011), 3 descendants of its own
- K121085: Het Bipolar Ligator System (2012), 2 descendants of its own
- K140422: Het Systems, LLC, Het Bipolar Ligator System (2014), 1 descendant of its own
- K200146: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor (2020), 0 descendants of its own

## Indications for use
The DynaBite HOT Biopsy Forceps is intended for uses in a gastrointestinal endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery.

Source page: https://510kreport.com/device/K970083
Methodology: https://510kreport.com/methodology