510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022198Substantially Equivalent

Endoscope Set for Magnetic Resonance (Mr), Models 8767.412, 8767.121 & 8767.452

Richard Wolf Medical Instruments Corp., Vernon Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022198 is the FDA 510(k) clearance record for ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452, a class II device, cleared for Richard Wolf Medical Instruments Corp. 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 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show no recalls naming K022198.

Clearance record

Decision date
Received
(259 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Richard Wolf Medical Instruments Corp. 353 Corporate Woods Pkwy., Vernon Hills IL
510(k) summary
Summary PDF
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