The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Minop Disposable Introducer 26f.
| Device ID | K142315 |
| 510k Number | K142315 |
| Device Name: | MINOP Disposable Introducer 26F |
| Classification | Endoscope, Neurological |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy Racosky |
| Correspondent | Corina Duffy MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-19 |
| Decision Date | 2014-11-14 |