510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030194Substantially Equivalent

Xues-41 Endoscopic Electrosurgical Unit

Olympus Optical Co., Ltd., Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030194 is the FDA 510(k) clearance record for XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT, a class II device, cleared for The Olympus Optical Co. on under FDA product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)). FDA records list 48 510(k) clearances for The Olympus Optical Co., from to . As of , FDA records show 3 recalls naming K030194.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
The Olympus Optical Co. Endoscope Division, Melville NY
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KNS

Trailing 12 months
4 clearances under product code KNS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KNS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260