ZZIREN 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)

Q: What is the product code of K242901?

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

FDA 510(k) K242901 · Tools For Surgery, LLC

Substantially Equivalent

510(k) numberK242901

Submission

Device name: ZZIREN 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)
Applicant: Tools For Surgery, LLC
East Setauket, NY, US
Received: September 23, 2024
Decision date: January 10, 2025
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

Other 510(k)s with product code KNT

510(k)	Device	Applicant	Decision
K261890	52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special	Boehringer Laboratories, LLC	08/14/2026SE
K253514	Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional	C.R. Bard, Inc.	07/10/2026SE
K250389	XNY Disposable Gastric Calibration TubeKNT · Traditional	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd	04/10/2025SE
K243228	Flexi-Seal AIR (with ENFit Connector)KNT · Traditional	Convatec	03/28/2025SE
K242336	hygh-tec Drainage IIKNT · Traditional	Amb Medtec	01/17/2025SE
K241169	Entarik NI Feeding Tube SystemKNT · Traditional	Gravitas Medical, Inc.	11/22/2024SE
K241185	CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional	Avanos Medical, Inc.	10/25/2024SE
K240965	CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional	Avanos Medical, Inc.	06/06/2024SE
K233591	StylusKNT · Traditional	Degania Silicone , Ltd.	05/31/2024SE
K241039	ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017)…KNT · Special	Reshape Lifesciences	05/16/2024SE

More from Reshape Lifesciences

510(k)	Device	Decision
K220218	Siren SGTKNT · Traditional	05/18/2022SE
K040109	Hemorrhage Occluder PinGDW · Traditional	03/25/2004SE
K040110	Easy Loop, Model EZL-01EZP · Traditional	03/24/2004SE

Questions and answers

When was ZZIREN 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) cleared by the FDA?

ZZIREN 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) (K242901) received a 510(k) decision of Substantially Equivalent on January 10, 2025, 109 days after the submission was received.

What is the product code of K242901?

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