The following data is part of a premarket notification filed by Icecure Medical Ltd. with the FDA for Icesence 3.
| Device ID | K102360 |
| 510k Number | K102360 |
| Device Name: | ICESENCE 3 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ICECURE MEDICAL LTD. HAESHEL 7 Caesaria, IL 38900 |
| Contact | Elisabeth Sadka |
| Correspondent | Elisabeth Sadka ICECURE MEDICAL LTD. HAESHEL 7 Caesaria, IL 38900 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-19 |
| Decision Date | 2010-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290015487160 | K102360 | 000 |
| 07290015487085 | K102360 | 000 |
| 07290015487054 | K102360 | 000 |
| 07290015487047 | K102360 | 000 |
| 07290015487030 | K102360 | 000 |
| 07290015487023 | K102360 | 000 |