510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844765Substantially Equivalent

Accessory Set for CO2 Laser Bronchoscopy Instrumen

Laser Spectrum, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844765 is the FDA 510(k) clearance record for ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN, a class I device, cleared for Laser Spectrum, Inc. on under FDA product code EWQ (Saw, Surgical, Ent (Electric Or Pneumatic)). FDA records list 5 510(k) clearances for Laser Spectrum, Inc., from to . As of , FDA records show no recalls naming K844765.

Clearance record

Decision date
Received
(122 days to decision)
Product code
EWQ Saw, Surgical, Ent (Electric Or Pneumatic)
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Laser Spectrum, Inc. 100 S. Wacker Dr., Chicago IL
Third party review
No

Clearances, product code EWQ

Trailing 12 months

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

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