510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010303Substantially Equivalent

Artscan Cartilage Stiffness Testing Device

Artscan Medical Innovations, Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010303 is the FDA 510(k) clearance record for ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE, a class II device, cleared for Artscan Medical Innovations on under FDA product code NGR (Tester, Stiffness, Cartilage, Arthroscopic). FDA records list one 510(k) clearance for Artscan Medical Innovations. As of , FDA records show no recalls naming K010303.

Clearance record

Decision date
Received
(280 days to decision)
Product code
NGR Tester, Stiffness, Cartilage, Arthroscopic
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Applicant
Artscan Medical Innovations 4804 Oin Oak Rd., Akron OH
510(k) summary
Summary
Third party review
No

Clearances, product code NGR

Trailing 12 months

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

FDA records show no clearances under product code NGR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NGR, 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