ClearEndoclip
FDA 510(k) K200217 · Finemedix Co., Ltd.
510(k) numberK200217
Submission
- Device name
- ClearEndoclip
- Applicant
- Finemedix Co., Ltd.
Daegu, KR - Received
- January 28, 2020
- Decision date
- October 5, 2020
- 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.
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| 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 |
|---|---|---|
| K251478 | ClearTip TBNA TypeKTI · Traditional | 04/16/2026SE |
| K250994 | ClearTip FNA and FNB TypesFCG · Traditional | 08/21/2025SE |
| K242857 | ClearHemograsperKGE · Traditional | 05/21/2025SE |
| K242134 | ClearCap Distal AttachmentOCX · Special | 08/20/2024SE |
| K231267 | ClearTipFCG · Traditional | 06/30/2023SE |
| K202616 | ClearCap Distal AttachmentOCX · Traditional | 02/19/2021SE |
| K183021 | ClearEndoclipPKL · Traditional | 06/28/2019SE |
| K183289 | ClearGrasp SnareFDI · Traditional | 03/06/2019SE |
| K181690 | Clear-Jet Injection CatheterFBK · Traditional | 12/21/2018SE |
| K180363 | Clear-Tip EUS-FNAFCG · Traditional | 11/01/2018SE |
Questions and answers
When was ClearEndoclip cleared by the FDA?
ClearEndoclip (K200217) received a 510(k) decision of Substantially Equivalent on October 5, 2020, 251 days after the submission was received.
What is the product code of K200217?
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.