Disposable Polypectomy Snare
FDA 510(k) K213222 · Beijing Zksk Technology Co., Ltd.
510(k) numberK213222
Submission
- Device name
- Disposable Polypectomy Snare
- Applicant
- Beijing Zksk Technology Co., Ltd.
Beijing, CN - Received
- September 29, 2021
- Decision date
- June 6, 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
Other 510(k)s with product code FDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251692 | Advanced Tissue Resection DeviceFDI · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 02/21/2026SE |
| K221713 | Polypectomy SnareFDI · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/03/2023SE |
| K220846 | Core-SnareFDI · Traditional | Incore Co., Ltd. | 11/21/2022SE |
| K220089 | Disposable Polyp SnareFDI · Traditional | Jiangsu Vedkang Medical Science and Technology… | 09/22/2022SE |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareFDI · Traditional | Yangzhou Fartley Medical Instrument Technology… | 06/27/2022SE |
| K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…FDI · Special | STERIS Corporation | 10/07/2021SE |
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy SnaresFDI · Special | Boston Scientific Corporation | 10/08/2020SE |
| 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 |
| K191048 | AcuSnare Polypectomy Snare - DuckbillFDI · Special | Wilson-Cook Medical, Inc. | 07/18/2019SE |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242192 | Disposable SphincterotomeKNS · Traditional | 02/06/2025SE |
| K231721 | Disposable Hot Biopsy ForcepsKGE · Traditional | 12/14/2023SE |
| K213217 | Disposable hemoclipPKL · Traditional | 11/14/2022SE |
| K213223 | Multi-Band LigatorFHN · Traditional | 06/06/2022SE |
| K213239 | Endoscopic Injection NeedleFBK · Traditional | 06/02/2022SE |
Questions and answers
When was Disposable Polypectomy Snare cleared by the FDA?
Disposable Polypectomy Snare (K213222) received a 510(k) decision of Substantially Equivalent on June 6, 2022, 250 days after the submission was received.
What is the product code of K213222?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.