K021050 is an FDA 510(k) clearance for the KSEA NEUROENDOSCOPES AND ACCESSORIES. This device is classified as a Endoscope, Neurological (Class II - Special Controls, product code GWG).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 26, 2002, 86 days after receiving the submission on April 1, 2002.
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 | K021050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2002 |
| Decision Date | June 26, 2002 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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). |