FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Sphincterotome
K Number: K222421
·
Decision May 3, 2023
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
17
Review Days
265
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Basic Information
- Device Name
- Sphincterotome
- K Number
- K222421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Date Received
- August 11, 2022
- Decision Date
- May 3, 2023
- Product Code
- KNS
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.
Sphincterotome
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Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
FDA 510(k)
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Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
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FDA Class 2
·Gastroenterology, Urology
SureTome SW Sphincterotome with DomeTip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K221713 | Polypectomy Snare | Mar 3, 2023 | Substantially Equivalent |
| K213143 | Hemoclip | Jul 12, 2022 | Substantially Equivalent |
| K213578 | Balloon Dilatation Catheter | Apr 6, 2022 | Substantially Equivalent |
| K211787 | Hemoclip | Mar 3, 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 |