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
K984521Substantially Equivalent

Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351

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

K984521 is the FDA 510(k) clearance record for RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351, a class I device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code EQL (Laryngostroboscope). FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show no recalls naming K984521.

Clearance record

Decision date
Received
(86 days to decision)
Product code
EQL Laryngostroboscope
Regulation
21 CFR 874.4750
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Richard Wolf Medical Instruments Corp. 353 Corporate Woods Pkwy., Vernon Hills IL
510(k) summary
Summary
Third party review
No

Clearances, product code EQL

Trailing 12 months

FDA records hold no clearances under product code EQL in the trailing twelve months.

FDA records show no clearances under product code EQL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EQL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260