510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830434Substantially Equivalent

Disposable Intra-Articular Blade

Concept, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830434 is the FDA 510(k) clearance record for DISPOSABLE INTRA-ARTICULAR BLADE, a class I device, cleared for Concept, Inc. on under FDA product code GFA (Blade, Saw, General & Plastic Surgery, Surgical). FDA records list 83 510(k) clearances for Concept, Inc., from to . As of , FDA records show no recalls naming K830434.

Clearance record

Decision date
Received
(62 days to decision)
Product code
GFA Blade, Saw, General & Plastic Surgery, Surgical
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Concept, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GFA

Trailing 12 months

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

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