Product code KNT

Current FDA Classification

Device name
Tubes, Gastrointestinal (And Accessories)
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5980
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible

Related 510(k) Records

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
K241185CORGRIP* SR NG/NI Tube Retention SystemAvanos Medical, Inc.2024-10-25
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
K230131ReShape Calibration TubesReshape Lifesciences2023-02-15
K221400hygh-tec drainageCreative Balloons GmbH2023-02-09
K222085Standard Tapered Bougie, 38 Fr.Standard Bariatrics, Inc.2022-10-31
K212316DoubleChek DC-1001Nasogastric Feeding Solutions, Ltd.2022-09-30
K221898Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences2022-07-28
K212407Gastric Lightguide (GLG)Naser Dib Gabinet Lekarksi Nasmed2022-07-26
K220455Lap-Band System Calibration TubeReshape Lifesciences2022-06-07
K220218Siren SGTTools For Surgery, LLC2022-05-18
K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc.2022-04-22
K212444Qora Stool Management KitCm Technologies, Inc.2021-11-17
K212728Standard Bougie, 38 Fr. and Hand PumpStandard Bariatrics2021-09-23
K210437Standard Bougie, 38 Fr.Standard Bariatrics2021-06-29
K211072Safety Trocar CannulaBoston Scientific Corporation2021-04-27
K202748Enteral Feeding CatheterMedcaptain Life Science Co., Ltd.2021-04-09

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