510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130357Substantially Equivalent

Superdimension Triple-Needle Cytology Brush

Medtronic, Inc., Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130357 is the FDA 510(k) clearance record for SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH, a class II device, cleared for Covidien, LLC on under FDA product code BTG (Brush, Biopsy, Bronchoscope (Non-Rigid)). FDA's definition for product code BTG reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K130357.

Clearance record

Decision date
Received
(266 days to decision)
Product code
BTG Brush, Biopsy, Bronchoscope (Non-Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Covidien, LLC 161 Cheshire Ln., Suite 100, Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTG

Trailing 12 months

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

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