The following data is part of a premarket notification filed by Mst - Medical Surgery Technologies Ltd. with the FDA for Autolap System.
| Device ID | K131375 |
| 510k Number | K131375 |
| Device Name: | AUTOLAP SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MST - MEDICAL SURGERY TECHNOLOGIES LTD. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | John J Smith, M.d., J.d. |
| Correspondent | John J Smith, M.d., J.d. MST - MEDICAL SURGERY TECHNOLOGIES LTD. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016648331 | K131375 | 000 |
| 27290016648304 | K131375 | 000 |
| 27290016648298 | K131375 | 000 |
| 27290016648281 | K131375 | 000 |
| 27290016648274 | K131375 | 000 |
| 17290016648260 | K131375 | 000 |
| 17290016648246 | K131375 | 000 |
| 17290016648239 | K131375 | 000 |
| 17290016648222 | K131375 | 000 |
| 17290016648208 | K131375 | 000 |
| 17290016648079 | K131375 | 000 |
| 27290016648311 | K131375 | 000 |
| 27290016648328 | K131375 | 000 |
| 07290016648119 | K131375 | 000 |
| 17290016648109 | K131375 | 000 |
| 07290016648096 | K131375 | 000 |
| 07290016648089 | K131375 | 000 |
| 07290016648072 | K131375 | 000 |
| 07290016648058 | K131375 | 000 |
| 07290016648034 | K131375 | 000 |
| 07290016648027 | K131375 | 000 |
| 07290016648010 | K131375 | 000 |
| 07290016648003 | K131375 | 000 |
| 17290016648062 | K131375 | 000 |