Disposable Polyp Snare
FDA 510(k) K220089 · Jiangsu Vedkang Medical Science and Technology Co., Ltd.
510(k) numberK220089
Submission
- Device name
- Disposable Polyp Snare
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Changzhou, CN - Received
- January 11, 2022
- Decision date
- September 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDI – Snare, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K220846 | Core-SnareFDI · Traditional | Incore Co., Ltd. | 11/21/2022SE |
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| K200745 | Lariat, Hot/Cold SnareFDI · Special | United States Endoscopy Group, Inc. | 04/21/2020SE |
| K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareFDI · Traditional | Intelligent Endoscopy | 11/22/2019SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K232825 | Disposable SphincterotomeKNS · Traditional | 03/29/2024SE |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-…GCA · Traditional | 02/26/2024SE |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter)FGE · Traditional | 02/15/2024SE |
| K230598 | Stone Extraction BasketsLQR · Traditional | 09/12/2023SE |
| K222146 | Disposable Endoscopic HemoclipPKL · Traditional | 03/28/2023SE |
| K213914 | Injection NeedleFBK · Traditional | 07/29/2022SE |
Questions and answers
When was Disposable Polyp Snare cleared by the FDA?
Disposable Polyp Snare (K220089) received a 510(k) decision of Substantially Equivalent on September 22, 2022, 254 days after the submission was received.
What is the product code of K220089?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.