510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790845Substantially Equivalent

Dualume Laryngeal Examination Telescope

National Medical Technology, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790845 is the FDA 510(k) clearance record for DUALUME LARYNGEAL EXAMINATION TELESCOPE, a class II device, cleared for National Medical Technology 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 4 510(k) clearances for National Medical Technology, from to . As of , FDA records show no recalls naming K790845.

Clearance record

Decision date
Received
(81 days to decision)
Product code
ENZ Telescope, Laryngeal-Bronchial
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
National Medical Technology 803 N. Front St. Suite 3, Mchenry IL
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