510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220006Unknown

ProdiGI

Medtronic, Inc., Santa Clara CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220006 is the FDA 510(k) clearance record for ProdiGI, a class II device, cleared for Covidien, LLC on under FDA product code QSW (Endoscopic Traction Device). FDA's definition for product code QSW reads: "An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming DEN220006.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QSW Endoscopic Traction Device
Regulation
21 CFR 876.4410
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien, LLC 3062 Bunkerhill Ln., Santa Clara CA
Third party review
No

Clearances, product code QSW

Trailing 12 months

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

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