K954910 is an FDA 510(k) clearance for the KARL STORZ OPTICAL MEDIASTINOSCOPE. This device is classified as a Mediastinoscope, Surgical (Class II - Special Controls, product code EWY).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 3, 1995, 9 days after receiving the submission on October 25, 1995.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4720. 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 | K954910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1995 |
| Decision Date | November 03, 1995 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWY — Mediastinoscope, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4720 |
| 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). |