Siren SGT

FDA 510(k) K220218 · Tools For Surgery, LLC

Substantially Equivalent

510(k) numberK220218

Submission

Device name
Siren SGT
Applicant
Tools For Surgery, LLC
East Setauket, NY, US
Received
January 26, 2022
Decision date
May 18, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNT – Tubes, Gastrointestinal (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

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K250389XNY Disposable Gastric Calibration TubeKNT · Traditional Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd04/10/2025SE
K243228Flexi-Seal AIR (with ENFit Connector)KNT · Traditional Convatec03/28/2025SE
K242336hygh-tec Drainage IIKNT · Traditional Amb Medtec01/17/2025SE
K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT…KNT · Traditional Tools For Surgery, LLC01/10/2025SE
K241169Entarik NI Feeding Tube SystemKNT · Traditional Gravitas Medical, Inc.11/22/2024SE
K241185CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional Avanos Medical, Inc.10/25/2024SE
K240965CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional Avanos Medical, Inc.06/06/2024SE
K233591StylusKNT · Traditional Degania Silicone , Ltd.05/31/2024SE

More from Degania Silicone , Ltd.

510(k)DeviceDecision
K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT…KNT · Traditional 01/10/2025SE
K040109Hemorrhage Occluder PinGDW · Traditional 03/25/2004SE
K040110Easy Loop, Model EZL-01EZP · Traditional 03/24/2004SE

Questions and answers

When was Siren SGT cleared by the FDA?

Siren SGT (K220218) received a 510(k) decision of Substantially Equivalent on May 18, 2022, 112 days after the submission was received.

What is the product code of K220218?

The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.