# K963517: Spectra Science Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Spectrascience, Inc.
- Decided: Dec 2, 1996 after 90 days
- Product code: FCL (Forceps, Biopsy, Non-Electric)
- Device class: 1
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- 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) U.S. Endoscopy Group Inc., Disposable Biopsy Forceps Model #00711206: named in the summary without a submission number

## Indications for use
The SpectraScience Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for histologic examination. The instruments are intended for endoscopic gastrointestinal and urologic biopsy and should not be used for any purpose other than their intended function.

Source page: https://510kreport.com/device/K963517
Methodology: https://510kreport.com/methodology