510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213194Substantially Equivalent

HD Mediastinoscope

Karl Storz Endoscopy-America, Inc., El Segundo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213194 is the FDA 510(k) clearance record for HD Mediastinoscope, a class II device, cleared for Karl Storz Endoscopy America, Inc. on under FDA product code EWY (Mediastinoscope, Surgical). FDA's definition for product code EWY 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 402 510(k) clearances for Karl Storz Endoscopy America, Inc., from to . As of , FDA records show no recalls naming K213194.

Clearance record

Decision date
Received
(267 days to decision)
Product code
EWY Mediastinoscope, Surgical
Regulation
21 CFR 874.4720
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave., El Segundo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EWY

Trailing 12 months
1 clearance under product code EWY in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260