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FDA 510(k)

Siren SGT

K-Number: K220218 · 2022-05-18

ApplicantTools For Surgery, LLC
Decision Date2022-05-18
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Siren SGT is a medical device manufactured by Tools For Surgery, LLC. It received FDA 510(k) clearance on 2022-05-18 under approval number K220218. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Siren SGT?

Siren SGT is a medical device that received FDA 510(k) clearance on 2022-05-18. It is manufactured by Tools For Surgery, LLC. The 510(k) number is K220218.

When was Siren SGT approved by the FDA?

Siren SGT received FDA 510(k) clearance on 2022-05-18, under approval number K220218.

What company makes Siren SGT?

Siren SGT is manufactured by Tools For Surgery, LLC.

What is the FDA product code for Siren SGT?

The FDA product code for Siren SGT is KNT.

Other Devices by Tools For Surgery, LLC

K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

Related Devices (Code: KNT)

K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc. K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd. K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd. K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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