Disposable Hemoclip (AF series)
FDA 510(k) K231633 · Alton (Shanghai) Medical Instruments Co., Ltd.
510(k) numberK231633
Submission
- Device name
- Disposable Hemoclip (AF series)
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd.
Shanghai, CN - Received
- June 5, 2023
- Decision date
- January 11, 2024
- 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 |
|---|---|---|
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | 06/18/2025SE |
| K242635 | Endoscopic Distal Attachment (AF-D series)FDS · Traditional | 05/30/2025SE |
| K241679 | Disposable Cytology Brush (AF series)KTI · Traditional | 03/04/2025SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | 10/01/2024SE |
| K230925 | Disposable Injection Needle AF seriesFBK · Traditional | 09/27/2023SE |
Questions and answers
When was Disposable Hemoclip (AF series) cleared by the FDA?
Disposable Hemoclip (AF series) (K231633) received a 510(k) decision of Substantially Equivalent on January 11, 2024, 220 days after the submission was received.
What is the product code of K231633?
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.