The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Video Assisted Thoracic Surgery (vats) Instruments.
| Device ID | K170683 |
| 510k Number | K170683 |
| Device Name: | Aesculap Video Assisted Thoracic Surgery (VATS) INstruments |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Jessica Stigliano |
| Correspondent | Jessica Stigliano Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2018-02-20 |
| Summary: | summary |