The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Electrocautery Shroud.
| Device ID | K953418 |
| 510k Number | K953418 |
| Device Name: | ELECTROCAUTERY SHROUD |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale, AZ 85306 |
| Contact | Kurt Hasper |
| Correspondent | Kurt Hasper I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale, AZ 85306 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-14 |
| Decision Date | 1995-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817688022404 | K953418 | 000 |
| 00817688021087 | K953418 | 000 |
| 00817688021100 | K953418 | 000 |
| 00817688021124 | K953418 | 000 |
| 00817688021162 | K953418 | 000 |
| 00817688021186 | K953418 | 000 |
| 00817688021209 | K953418 | 000 |
| 00817688021223 | K953418 | 000 |
| 00817688021247 | K953418 | 000 |
| 00817688021933 | K953418 | 000 |
| 00817688021940 | K953418 | 000 |
| 00817688021971 | K953418 | 000 |
| 00817688021988 | K953418 | 000 |
| 00817688021995 | K953418 | 000 |
| 00817688022268 | K953418 | 000 |
| 00817688022299 | K953418 | 000 |
| 00817688021063 | K953418 | 000 |