510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993568Substantially Equivalent

Machida Flexible Neuro-Endoscope, Models Neu-4, Neu-4L

Machida Endoscope Co., Ltd., Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993568 is the FDA 510(k) clearance record for MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L, a class II device, cleared for Machida Endoscope Co., Ltd. on under FDA product code GWG (Endoscope, Neurological). FDA's definition for product code GWG reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list one 510(k) clearance for Machida Endoscope Co., Ltd. As of , FDA records show no recalls naming K993568.

Clearance record

Decision date
Received
(144 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Machida Endoscope Co., Ltd. 13-8, Honkomagome 6-Chome,, Tokyo, JP
510(k) summary
Summary
Third party review
No

Clearances, product code GWG

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