510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944032Substantially Equivalent

Video Scope System (Laryngoscope)

JEDMED Instrument Company, St.Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944032 is the FDA 510(k) clearance record for VIDEO SCOPE SYSTEM (LARYNGOSCOPE), a class II device, cleared for Jedmed Instrument Co. on under FDA product code ENZ (Telescope, Laryngeal-Bronchial). FDA's definition for product code ENZ 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 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K944032.

Clearance record

Decision date
Received
(394 days to decision)
Product code
ENZ Telescope, Laryngeal-Bronchial
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Jedmed Instrument Co. 6096 Lemay Ferry Rd., St.Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code ENZ

Trailing 12 months

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

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