510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910964Substantially Equivalent

Hot Biopsy Forceps

Boston Scientific Corporation, Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910964 is the FDA 510(k) clearance record for HOT BIOPSY FORCEPS, a class II device, cleared for Symbiosis Corp. on under FDA product code KGE (Forceps, Biopsy, Electric). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K910964.

Clearance record

Decision date
Received
(57 days to decision)
Product code
KGE Forceps, Biopsy, Electric
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Symbiosis Corp. 5801 Miami Lakes Dr., Miami Lakes FL
Third party review
No

Clearances, product code KGE

Trailing 12 months
1 clearance under product code KGE in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260