SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
FDA 510(k) K190512 · Intelligent Endoscopy
510(k) numberK190512
Submission
- Device name
- SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
- Applicant
- Intelligent Endoscopy
Clemmons, NC, US - Received
- March 1, 2019
- Decision date
- November 22, 2019
- 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 |
| K213222 | Disposable Polypectomy SnareFDI · Traditional | Beijing Zksk Technology Co., Ltd. | 06/06/2022SE |
| 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 |
| K191048 | AcuSnare Polypectomy Snare - DuckbillFDI · Special | Wilson-Cook Medical, Inc. | 07/18/2019SE |
Questions and answers
When was SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare cleared by the FDA?
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (K190512) received a 510(k) decision of Substantially Equivalent on November 22, 2019, 266 days after the submission was received.
What is the product code of K190512?
The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.