SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
FDA 510(k) clearance K212860 · decided 2021-10-07
Clearance details
- K-number
- K212860
- Device name
- SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-09-08
- Decision date
- 2021-10-07
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FDI
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| Advanced Tissue Resection Device (K251692) | Micro-Tech (Nanjing) Co., Ltd. | 2026-02-21 |
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| CORE-SNARE (K220846) | Incore Co., Ltd. | 2022-11-21 |
| Disposable Polyp Snare (K220089) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-09-22 |
| Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (K220790) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-27 |
| Disposable Polypectomy Snare (K213222) | Beijing Zksk Technology Co., Ltd. | 2022-06-06 |
| Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares (K202478) | Boston Scientific Corporation | 2020-10-08 |
| Lariat, Hot/Cold Snare (K200745) | United States Endoscopy Group, Inc. | 2020-04-21 |
| SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (K190512) | Intelligent Endoscopy | 2019-11-22 |
| AcuSnare Polypectomy Snare - Duckbill (K191048) | Wilson-Cook Medical, Inc. | 2019-07-18 |
| ClearGrasp Snare (K183289) | Finemedix Co., Ltd. | 2019-03-06 |
| Roth Net Retriever Product Line (K182909) | United States Endoscopy Group, Inc. | 2018-11-21 |
Recalls involving this device
No recalls on record reference this clearance.