Single Use Repositionable Clip
8 catalogue numbers from HX-202LR, listed by Olympus Medical Systems Corp., Japan, under Hemostatic Metal Clip For The Gi Tract. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
8catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (9), Jiangsu (4), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Ningbo Huakun Medical Equipment Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
Showing 12 of 17. All 17 manufacturers in China registered for Hemostatic Metal Clip For The Gi Tract
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | PKL |
| Device type | Hemostatic Metal Clip For The Gi Tract |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4400 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2025-11-24 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 5 |
| Distribution end date | 2022-08-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HX-202LR | In distribution | |
| HX-202UR | In distribution | |
| HX-202LR | In distribution | |
| HX-202UR | In distribution | |
| HX-202LR | Withdrawn | |
| HX-202LR | Withdrawn | |
| HX-202UR | Withdrawn | |
| HX-202UR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hemostatic Metal Clip For The Gi Tract | Hangzhou AGS MedTech Co., Ltd. | 368 |
| Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | 160 |
| Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 80 |
| SureClip | Micro-Tech (Nanjing) Co., Ltd. | 38 |
| Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 32 |
| Zksk | Beijing Zksk Technology Co., Ltd. | 30 |
| RiteClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 30 |
| S.t.a.r(TM) Disposable Hemostatic Closure Clip Device | Micro-Tech (Nanjing) Co., Ltd. | 24 |
| Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 18 |
| Otsc System Set | Ovesco Endoscopy AG | 17 |
| Otsc System Set | Ovesco Endoscopy USA | 17 |
| Single Use Multiclip Device | Micro-Tech (Nanjing) Co., Ltd. | 12 |
Showing 12 of 52. All products under Hemostatic Metal Clip For The Gi Tract
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260580 | 2026-05-21 |
| K240617 | 2024-06-03 |
| K183590 | 2019-08-01 |
| K123601 | 2013-04-29 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2023-05-04 | Class II | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include rep | 340 pieces |
| Olympus Corporation of the Americas | UDI-DI | 2023-05-04 | Class II | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include rep | 45 pieces |
| Olympus Corporation of the Americas | UDI-DI | 2023-05-04 | Class II | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include rep | 13707 pieces |
| Olympus Corporation of the Americas | UDI-DI | 2023-05-04 | Class II | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include rep | 3795 pieces |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.