K142315 is an FDA 510(k) clearance for the MINOP Disposable Introducer 26F. This device is classified as a Endoscope, Neurological (Class II - Special Controls, product code GWG).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 14, 2014, 87 days after receiving the submission on August 19, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1480. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K142315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2014 |
| Decision Date | November 14, 2014 |
| Days to Decision | 87 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GWG — Endoscope, Neurological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1480 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |