510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973611Substantially Equivalent

Spectrascience Reusable Biopsy Forceps

Spectrascience, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973611 is the FDA 510(k) clearance record for SPECTRASCIENCE REUSABLE BIOPSY FORCEPS, a class I device, cleared for Spectrascience, Inc. on under FDA product code FCL (Forceps, Biopsy, Non-Electric). FDA records list 2 510(k) clearances for Spectrascience, Inc., from to . As of , FDA records show no recalls naming K973611.

Clearance record

Decision date
Received
(71 days to decision)
Product code
FCL Forceps, Biopsy, Non-Electric
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Spectrascience, Inc. 3650 Annapolis Ln., Suite 101, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code FCL

Trailing 12 months

FDA records hold no clearances under product code FCL in the trailing twelve months.

FDA records show no clearances under product code FCL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260