510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943904Substantially Equivalent

Rigid Telescopes

Karl Storz Endoskop GmbH, Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943904 is the FDA 510(k) clearance record for RIGID TELESCOPES, a class II device, cleared for Karl Storz Endoskop GmbH 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 11 510(k) clearances for Karl Storz Endoskop GmbH, from to . As of , FDA records show no recalls naming K943904.

Clearance record

Decision date
Received
(64 days to decision)
Product code
ENZ Telescope, Laryngeal-Bronchial
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Karl Storz Endoskop GmbH 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
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