510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883944Substantially Equivalent

Mec-1 Video Combo System

Medical Concepts, Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883944 is the FDA 510(k) clearance record for MEC-1 VIDEO COMBO SYSTEM, a class I device, cleared for Medical Concepts, Inc. on under FDA product code FTS (Camera, Cine, Endoscopic, With Audio). FDA records list 5 510(k) clearances for Medical Concepts, Inc., from to . As of , FDA records show no recalls naming K883944.

Clearance record

Decision date
Received
(9 days to decision)
Product code
FTS Camera, Cine, Endoscopic, With Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medical Concepts, Inc. 310 Olive St., Santa Barbara CA
Third party review
No

Clearances, product code FTS

Trailing 12 months

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

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