510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894419Substantially Equivalent

Gastro Enterological Bioptome

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

K894419 is the FDA 510(k) clearance record for GASTRO ENTEROLOGICAL BIOPTOME, a class II device, cleared for Symbiosis Corp. on under FDA product code KNW (Instrument, Biopsy). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K894419.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Symbiosis Corp. 8600 NW 41 St., Miami FL
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to November 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260
November 20260