KNT · Tubes, Gastrointestinal (And Accessories)

Device class

Class II

Regulation 876.5980

Total clearances

2020-03-13 → 2026-08-14

Last 12 months

Unique sponsors

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.5980

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Reshape Lifesciences	4	0	2024-05-16
Standard Bariatrics	4	0	2022-10-31
Avanos Medical, Inc.	3	0	2024-10-25
Boehringer Laboratories	3	1	2026-08-14
Endolumik	2	0	2024-02-08
Tools For Surgery, LLC	2	0	2025-01-10
Applied Medical Technology, Inc.	2	0	2023-12-18
Gravitas Medical, Inc.	2	0	2024-11-22
Nasogastric Feeding Solutions, Ltd.	1	0	2022-09-30
Naser Dib Gabinet Lekarksi Nasmed	1	0	2022-07-26
Amb Medtec	1	0	2025-01-17
Creative Balloons GmbH	1	0	2023-02-09
Hangzhou Primecare Medical Co., Ltd.	1	0	2024-04-17
Medcaptain Life Science Co., Ltd.	1	0	2021-04-09
Cm Technologies, Inc.	1	0	2021-11-17
Wilson-Cook Medical, Inc.	1	0	2020-06-17
Boston Scientific Corporation	1	0	2021-04-27
Degania Silicone , Ltd.	1	0	2024-05-31
C.R. Bard, Inc.	1	1	2026-07-10
Prosys International, Ltd.	1	0	2020-03-13
Convatec	1	0	2025-03-28
Envizion Medical , Ltd.	1	0	2021-03-24
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd	1	0	2025-04-10
Actuated Medical, Inc.	1	0	2020-12-04

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4481	HCPCS	Tracheostoma filter, any type, any size, each ✓ CMS-verified description	High	Tracheostoma/stoma supplies, each replacement tube
43752	CPT	—	Medium	Nasogastric tube placement; includes fluoroscopic guidance
43753	CPT	—	Medium	Percutaneous placement of gastrostomy tube

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-14	K261890	Boehringer Laboratories, LLC	52Fr ViSiGi LUX; 52Fr ViSiGi 3D®
2026-07-10	K253514	C.R. Bard, Inc.	Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)
2025-04-10	K250389	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd	XNY Disposable Gastric Calibration Tube
2025-03-28	K243228	Convatec	Flexi-Seal AIR (with ENFit Connector)
2025-01-17	K242336	Amb Medtec	hygh-tec Drainage II
2025-01-10	K242901	Tools For Surgery, LLC	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)
2024-11-22	K241169	Gravitas Medical, Inc.	Entarik NI Feeding Tube System
2024-10-25	K241185	Avanos Medical, Inc.	CORGRIP* SR NG/NI Tube Retention System
2024-06-06	K240965	Avanos Medical, Inc.	CORTRAK* 2 Enteral Access System (20-0950)
2024-05-31	K233591	Degania Silicone , Ltd.	Stylus
2024-05-16	K241039	Reshape Lifesciences	ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
2024-05-06	K234033	Boehringer Laboratories, LLC	ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
2024-04-17	K240039	Hangzhou Primecare Medical Co., Ltd.	Enteral Feeding Sets
2024-02-08	K240069	Endolumik	Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
2024-01-26	K234145	Boehringer Laboratories	ViSiGi 3D Gastric Sizing Tube
2023-12-18	K222846	Applied Medical Technology, Inc.	AMT G-Tube Balloon Gastrostomy Feeding Device
2023-03-24	K230206	Gravitas Medical, Inc.	Entarik Feeding Tube System; Entarik Feeding Tube
2023-03-03	K222880	Endolumik, Inc.	Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
2023-02-15	K230131	Reshape Lifesciences	ReShape Calibration Tubes
2023-02-09	K221400	Creative Balloons GmbH	hygh-tec drainage
2022-10-31	K222085	Standard Bariatrics, Inc.	Standard Tapered Bougie, 38 Fr.
2022-09-30	K212316	Nasogastric Feeding Solutions, Ltd.	DoubleChek DC-1001
2022-07-28	K221898	Reshape Lifesciences	Gastrointestinal Boundary Identifier (GIBI HD)
2022-07-26	K212407	Naser Dib Gabinet Lekarksi Nasmed	Gastric Lightguide (GLG)
2022-06-07	K220455	Reshape Lifesciences	Lap-Band System Calibration Tube