Gastrointestinal Boundary Identifier (GIBI HD)

Q: What is the product code of K221898?

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) K221898 · Reshape Lifesciences

Substantially Equivalent

510(k) numberK221898

Submission

Device name: Gastrointestinal Boundary Identifier (GIBI HD)
Applicant: Reshape Lifesciences
San Clemente, CA, US
Received: June 30, 2022
Decision date: July 28, 2022
Decision: Substantially Equivalent (SESE)
Type: Special 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
K242901	ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional	Tools For Surgery, LLC	01/10/2025SE
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

More from Degania Silicone , Ltd.

510(k)	Device	Decision
K241039	ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017)…KNT · Special	05/16/2024SE
K230131	ReShape Calibration TubesKNT · Special	02/15/2023SE
K220455	Lap-Band System Calibration TubeKNT · Traditional	06/07/2022SE

Questions and answers

When was Gastrointestinal Boundary Identifier (GIBI HD) cleared by the FDA?

Gastrointestinal Boundary Identifier (GIBI HD) (K221898) received a 510(k) decision of Substantially Equivalent on July 28, 2022, 28 days after the submission was received.

What is the product code of K221898?

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