510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001339Substantially Equivalent

MRI Fastsystem Retractor System

Omni-Tract Surgical, Div. Minn. Scientific, Inc., Minneapolis MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001339 is the FDA 510(k) clearance record for MRI FASTSYSTEM RETRACTOR SYSTEM, a class I device, cleared for Omni-Tract Surgical, Div. Minn. Scientific, Inc. on under FDA product code GAD (Retractor). FDA records list 4 510(k) clearances for Omni-Tract Surgical, Div. Minn. Scientific, Inc., from to . As of , FDA records show no recalls naming K001339.

Clearance record

Decision date
Received
(20 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Omni-Tract Surgical, Div. Minn. Scientific, Inc. 1100 New Brighton Blvd., Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code GAD

Trailing 12 months

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

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