PKL · Hemostatic Metal Clip For The Gi Tract

Device class

Class II

Regulation 876.4400

Total clearances

2020-03-05 → 2026-08-10

Last 12 months

Unique sponsors

Definition

What is Hemostatic Metal Clip For The Gi Tract

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.4400

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
Hangzhou AGS MedTech Co., Ltd.	5	3	2026-08-10
Boston Scientific Corporation	4	0	2025-02-06
Micro-Tech (Nanjing) Co., Ltd.	4	1	2025-09-08
Ovesco Endoscopy AG	3	1	2025-12-18
Olympus Medical Systems Corp.	2	1	2026-05-21
STERIS Corporation	2	0	2025-04-18
Apollo Endosurgery, Inc.	1	0	2020-12-15
Anrei Medical (Hangzhou) Co., Ltd.	1	0	2020-10-19
Taurus Endoscopy	1	1	2026-03-12
Mirco-Tech (Nanjing) Co., Ltd.	1	0	2024-03-19
Incore Co., Ltd.	1	0	2022-06-23
Beijing Zksk Technology Co., Ltd.	1	0	2022-11-14
Wilson-Cook Medical, Inc.	1	0	2021-08-25
Ningbo Xinwell Medical Technology Co., Ltd.	1	0	2024-06-07
Jiangsu Vedkang Medical Science and Technology Co., Ltd.	1	0	2023-03-28
Finemedix Co., Ltd.	1	0	2020-10-05
Alton (Shanghai) Medical Instruments Co., Ltd.	1	0	2024-01-11
Zhejiang Soudon Medical Technology Co., Ltd.	1	0	2024-01-26
Yangzhou Fartley Medical Instrument Technology Co., Ltd.	1	0	2023-07-31
Promisemed Hangzhou Meditech Co., Ltd.	1	0	2024-07-12
Cook Endoscopy	1	0	2020-03-05
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.	1	0	2025-01-02
Zhejiang Chuangxiang Medical Technology Co., Ltd.	1	0	2022-05-27

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
43460	CPT	—	High	Endoscopic hemostasis with clip application in GI tract
43453	CPT	—	Medium	Endoscopic hemostasis/clipping for bleeding control in upper GI

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-10	K254069	Hangzhou AGS MedTech Co., Ltd.	Hemoclip (511 series, 543 series)
2026-05-21	K260580	Olympus Medical Systems Corp.	Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
2026-04-08	K252270	Hangzhou AGS MedTech Co., Ltd.	Hemoclip
2026-03-12	K253734	Taurus Endoscopy	Taurus Clip
2025-12-18	K251562	Ovesco Endoscopy AG	OTSCneo System Set (100.03n-14n, 100.27n-31n)
2025-11-12	K252271	Hangzhou AGS MedTech Co., Ltd.	Hemoclip
2025-09-08	K250229	Micro-Tech (Nanjing) Co., Ltd.	Dual Action Tissue Closure Device
2025-04-18	K250842	STERIS Corporation	PADLOCK CLIP EFTR Kit (00713229)
2025-02-06	K250066	Boston Scientific Corporation	Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
2025-01-02	K241005	Jiangxi Zhuoruihua Medical Instrument Co., Ltd.	Haemostasis Clips
2024-09-17	K240274	STERIS Corporation	PADLOCK CLIP EFTR Kit (00713229)
2024-08-26	K241858	Ovesco Endoscopy AG	BARS Set (100.60)
2024-07-12	K234124	Promisemed Hangzhou Meditech Co., Ltd.	Single Use Hemoclips
2024-06-07	K232969	Ningbo Xinwell Medical Technology Co., Ltd.	Disposable Hemostatic Clips
2024-06-03	K240617	Olympus Medical Systems Corp.	Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
2024-03-19	K233772	Mirco-Tech (Nanjing) Co., Ltd.	Disposable Dual Action Tissue Closure Device
2024-01-26	K232450	Zhejiang Soudon Medical Technology Co., Ltd.	Disposable Hemostatic Clips
2024-01-11	K231633	Alton (Shanghai) Medical Instruments Co., Ltd.	Disposable Hemoclip (AF series)
2023-07-31	K230004	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	Disposable Hemoclip
2023-03-28	K222146	Jiangsu Vedkang Medical Science and Technology Co., Ltd.	Disposable Endoscopic Hemoclip
2022-11-14	K213217	Beijing Zksk Technology Co., Ltd.	Disposable hemoclip
2022-09-14	K222503	Boston Scientific Corporation	Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
2022-08-04	K221124	Boston Scientific Corporation	MANTIS Clip
2022-07-12	K213143	Hangzhou AGS MedTech Co., Ltd.	Hemoclip
2022-06-23	K213338	Incore Co., Ltd.	CORE-CLIP