FDA.reportPublic FDA data

510(k) K230131

Device
ReShape Calibration Tubes
Applicant
Reshape Lifesciences
510(k) number
K230131
Product code
KNT
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-15
Date received
2023-01-17
Regulation
876.5980
Classification name
Tubes, Gastrointestinal (And Accessories)
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dov Gal
Address
1001 Calle Amanecer San Clemente CA US 92673 92673

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd2025-04-10
K243228Flexi-Seal AIR (with ENFit Connector)Convatec2025-03-28
K242336hygh-tec Drainage IIAmb Medtec2025-01-17
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)Tools For Surgery, LLC2025-01-10
K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc.2024-11-22
K240965CORTRAK* 2 Enteral Access System (20-0950)Avanos Medical, Inc.2024-06-06
K233591StylusDegania Silicone , Ltd.2024-05-31
K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)Reshape Lifesciences2024-05-16
K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC2024-05-06
K240039Enteral Feeding SetsHangzhou Primecare Medical Co., Ltd.2024-04-17
K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)Endolumik2024-02-08
K234145ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories2024-01-26
K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc.2023-12-18
K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc.2023-03-24
K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc.2023-03-03