The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Visual-ice Cryoablation System.
| Device ID | K113860 |
| 510k Number | K113860 |
| Device Name: | VISUAL-ICE CRYOABLATION SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL INC. 63 CHICORY CT. Lake Jackson, TX 77566 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney GALIL MEDICAL INC. 63 CHICORY CT. Lake Jackson, TX 77566 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867379000006 | K113860 | 000 |
| 00859019006011 | K113860 | 000 |
| 00859019006028 | K113860 | 000 |
| 00859019006035 | K113860 | 000 |
| 00859019006042 | K113860 | 000 |
| 00859019006059 | K113860 | 000 |
| 00859019006066 | K113860 | 000 |
| 00859019006073 | K113860 | 000 |
| 00859019006233 | K113860 | 000 |
| 00859019006240 | K113860 | 000 |
| 00859019006257 | K113860 | 000 |
| 00859019006264 | K113860 | 000 |
| 00859019006271 | K113860 | 000 |
| 00859019006288 | K113860 | 000 |
| 00859019006295 | K113860 | 000 |
| 00859019006301 | K113860 | 000 |
| 00859019006004 | K113860 | 000 |