510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861583Substantially Equivalent

CO2 Laser Bronchoscope System

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

K861583 is the FDA 510(k) clearance record for CO2 LASER BRONCHOSCOPE SYSTEM, a class II device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery). FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show no recalls naming K861583.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LLO Laser, Neodymium:Yag, Pulmonary Surgery
Regulation
21 CFR 874.4500
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Richard Wolf Medical Instruments Corp. 7046 Lyndon Ave., Rosemont IL
Third party review
No

Clearances, product code LLO

Trailing 12 months

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

FDA records show no clearances under product code LLO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLO, 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