510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984358Substantially Equivalent

Olympus Distal Attachment, Models Mh-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597

OLYMPUS Corporation of the Americas, Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984358 is the FDA 510(k) clearance record for OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597, a class II device, cleared for Olympus America, Inc. on under FDA product code FDS (Gastroscope And Accessories, Flexible/Rigid). FDA's definition for product code FDS reads: "To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available...". FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show 2 recalls naming K984358.

Clearance record

Decision date
Received
(284 days to decision)
Product code
FDS Gastroscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Summary
Third party review
No

Clearances, product code FDS

Trailing 12 months
8 clearances under product code FDS in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FDS, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20261
May 20260
June 20260
July 20260
August 20263
September 20261
October 20260