ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)

FDA 510(k) K241039 · Reshape Lifesciences

Substantially Equivalent

510(k) numberK241039

Submission

Device name
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
Applicant
Reshape Lifesciences
Irvine, CA, US
Received
April 16, 2024
Decision date
May 16, 2024
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)DeviceApplicantDecision
K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®KNT · Special Boehringer Laboratories, LLC08/14/2026SE
K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional C.R. Bard, Inc.07/10/2026SE
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
K230131ReShape Calibration TubesKNT · Special 02/15/2023SE
K221898Gastrointestinal Boundary Identifier (GIBI HD)KNT · Special 07/28/2022SE
K220455Lap-Band System Calibration TubeKNT · Traditional 06/07/2022SE

Questions and answers

When was ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) cleared by the FDA?

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (K241039) received a 510(k) decision of Substantially Equivalent on May 16, 2024, 30 days after the submission was received.

What is the product code of K241039?

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