# K973611: Spectrascience Reusable Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Spectrascience, Inc.
- Decided: Dec 2, 1997 after 71 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) SpectraScience™ Single Use Biopsy Forceps: named in the summary without a submission number

## Indications for use
The SpectraScience™ Reusable Biopsy Forceps are designed specifically to provide adjunctive illumination while collecting tissue endoscopically for histological 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/K973611
Methodology: https://510kreport.com/methodology