The following data is part of a premarket notification filed by Steris Corporation with the FDA for 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).
| Device ID | K212860 |
| 510k 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) |
| Classification | Snare, Flexible |
| Applicant | Steris Corporation 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin Steris Corporation 5976 Heisley Road Mentor, OH 44060 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-08 |
| Decision Date | 2021-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850261006217 | K212860 | 000 |
| 00850261006200 | K212860 | 000 |
| 00850261006125 | K212860 | 000 |
| 00850261006118 | K212860 | 000 |
| 00850261006101 | K212860 | 000 |
| 00850261006088 | K212860 | 000 |
| 00850261006071 | K212860 | 000 |