FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Hemoclip
K Number: K211787
·
Decision Mar 3, 2022
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
17
Review Days
267
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Basic Information
- Device Name
- Hemoclip
- K Number
- K211787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Date Received
- June 9, 2021
- Decision Date
- March 3, 2022
- Product Code
- PKL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKL), ordered by most recent decision date.
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)
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Other Clearances by Hangzhou AGS MedTech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252270 | Hemoclip | Apr 8, 2026 | Substantially Equivalent |
| K252271 | Hemoclip | Nov 12, 2025 | Substantially Equivalent |
| K241704 | Endoscopic Water Pump | Mar 20, 2025 | Substantially Equivalent |
| K222421 | Sphincterotome | May 3, 2023 | Substantially Equivalent |
| K221713 | Polypectomy Snare | Mar 3, 2023 | Substantially Equivalent |
| K213143 | Hemoclip | Jul 12, 2022 | Substantially Equivalent |
| K213578 | Balloon Dilatation Catheter | Apr 6, 2022 | Substantially Equivalent |
| K210406 | Bipolar Coagulation Foreceps | Oct 5, 2021 | Substantially Equivalent |
| K201121 | Sphincterotome | Feb 5, 2021 | Substantially Equivalent |
| K202237 | Locking device | Dec 23, 2020 | Substantially Equivalent |