510(k) Report

FDA applicant

Spectrascience, Inc.

Minnetonka, MN2 decisions1996–19970 recalls

FDA records 2 decisions for Spectrascience, Inc. (Minnetonka, MN) from 1996 to 1997: 2 510(k) clearances. All are in product code FCL (Forceps, Biopsy, Non-Electric). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Spectrascience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectrascience, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spectrascience, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spectrascience, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report