Disposable Hemoclip
FDA 510(k) K230004 · Yangzhou Fartley Medical Instrument Technology Co., Ltd.
510(k) numberK230004
Submission
- Device name
- Disposable Hemoclip
- Applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Yangzhou, CN - Received
- January 3, 2023
- Decision date
- July 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKL – Hemostatic Metal Clip For The Gi Tract
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4400
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
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.
Other 510(k)s with product code PKL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254069 | Hemoclip (511 series, 543 series)PKL · Traditional | Hangzhou AGS MedTech Co., Ltd. | 08/10/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | Olympus Medical Systems Corp. | 05/21/2026SE |
| K252270 | HemoclipPKL · Traditional | Hangzhou AGS MedTech Co., Ltd. | 04/08/2026SE |
| K253734 | Taurus ClipPKL · Traditional | Taurus Endoscopy | 03/12/2026SE |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n)PKL · Traditional | Ovesco Endoscopy AG | 12/18/2025SE |
| K252271 | HemoclipPKL · Traditional | Hangzhou AGS MedTech Co., Ltd. | 11/12/2025SE |
| K250229 | Dual Action Tissue Closure DevicePKL · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 09/08/2025SE |
| K250842 | PADLOCK CLIP EFTR Kit (00713229)PKL · Special | STERIS Corporation | 04/18/2025SE |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602)…PKL · Special | Boston Scientific Corporation | 02/06/2025SE |
| K241005 | Haemostasis ClipsPKL · Traditional | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 01/02/2025SE |
More from Jiangxi Zhuoruihua Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | 05/28/2026SE |
| K250732 | Disposable Endoscopy Valve SetODC · Traditional | 06/20/2025SE |
| K222980 | Pentax Medical Valve SetODC · Traditional | 11/21/2022SE |
| K220785 | Clean Connecting TubeOCX · Traditional | 09/27/2022SE |
| K220292 | Disposable Endoscope Injection NeedleFBK · Traditional | 08/19/2022SE |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareFDI · Traditional | 06/27/2022SE |
| K220210 | Disposable Endoscopy Adapter SetODC · Traditional | 06/17/2022SE |
Questions and answers
When was Disposable Hemoclip cleared by the FDA?
Disposable Hemoclip (K230004) received a 510(k) decision of Substantially Equivalent on July 31, 2023, 209 days after the submission was received.
What is the product code of K230004?
The FDA product code is PKL – Hemostatic Metal Clip For The Gi Tract, a Class II (moderate risk) device regulated under 21 CFR 876.4400.