The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Hybrid Trocar System.
| Device ID | K101937 |
| 510k Number | K101937 |
| Device Name: | HYBRID TROCAR SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Denise Adams |
| Correspondent | Denise Adams AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-08-11 |
| Summary: | summary |