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

Endoscopic Traction Device

21 CFR 876.4410 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QSW is the FDA product code for Endoscopic Traction Device, a class II device type, regulated under 21 CFR 876.4410. FDA's definition for this code 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 resection, exposure, and removal". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QSW
Device name
Endoscopic Traction Device
FDA definition
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 resection, exposure, and removal.
Regulation
21 CFR 876.4410
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QSW

By decision year
2 clearances under product code QSW with a decision year between 2022 and 2022, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QSW by decision year
YearClearances
20222

Applicants with the most clearances

Product code QSW
Applicants holding the most 510(k) clearances under product code QSW
ApplicantClearances
Medtronic, Inc.1
Micro-Tech (Nanjing) Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code