510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K943052Substantially Equivalent

Arthroscopic Telescopes

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

K943052 is the FDA 510(k) clearance record for ARTHROSCOPIC TELESCOPES, a class II device, cleared for Karl Storz Endoscopy on under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 402 510(k) clearances for KARL STORZ ENDOSCOPY-AMERICA, INC., from to . As of , FDA records show no recalls naming K943052.

Clearance record

Decision date
Received
(332 days to decision)
Product code
HRX Arthroscope
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Applicant
Karl Storz Endoscopy 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code HRX

Trailing 12 months
9 clearances under product code HRX in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code HRX, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20262
September 20260
October 20262
November 20260