510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061313Substantially Equivalent

Evis Exera 180 System

Olympus Medical Systems Corp., Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061313 is the FDA 510(k) clearance record for EVIS EXERA 180 SYSTEM, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)). FDA's definition for product code EOQ reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the...". FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show 19 recalls naming K061313.

Clearance record

Decision date
Received
(113 days to decision)
Product code
EOQ Bronchoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Olympus Medical Systems Corporation 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EOQ

Trailing 12 months
11 clearances under product code EOQ in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EOQ, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20262
May 20261
June 20261
July 20262
August 20260
September 20263
October 20260