The following data is part of a premarket notification filed by Icecure Medical Ltd. with the FDA for Icesense 3, Prosense, Multisense.
| Device ID | K183213 |
| 510k Number | K183213 |
| Device Name: | IceSense 3, ProSense, MultiSense |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | IceCure Medical LTD. 7 Haeshel St., P.O. Box 3163 Caesarea, IL 3088900 |
| Contact | Elisabeth Sadka |
| Correspondent | Zvi Ladin Boston MedTech Advisors Inc. 990 Washington Street Suite #204 Dedham, MA 02026 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290015487290 | K183213 | 000 |
| 07290015487160 | K183213 | 000 |
| 07290015487085 | K183213 | 000 |
| 07290015487054 | K183213 | 000 |
| 07290015487047 | K183213 | 000 |
| 07290015487030 | K183213 | 000 |
| 07290015487023 | K183213 | 000 |
| 07290015487092 | K183213 | 000 |
| 07290015487061 | K183213 | 000 |