510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K051972Substantially Equivalent

Karl Storz Trans-Nasal Esophagoscope

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

K051972 is the FDA 510(k) clearance record for KARL STORZ TRANS-NASAL ESOPHAGOSCOPE, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code EOX (Esophagoscope (Flexible Or Rigid)). FDA's definition for product code EOX 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 K051972.

Clearance record

Decision date
Received
(25 days to decision)
Product code
EOX Esophagoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4710
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EOX

Trailing 12 months

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

FDA records show no clearances under product code EOX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EOX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260