510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063786Substantially Equivalent

Endoscopic Insufflation Unit, Model Xecr-2

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

K063786 is the FDA 510(k) clearance record for ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope). FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show no recalls naming K063786.

Clearance record

Decision date
Received
(74 days to decision)
Product code
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corporation 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCX

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