K964281 is an FDA 510(k) clearance for the AESCULAP ANGLED NEUROENDOSCOPES. This device is classified as a Endoscope, Neurological (Class II - Special Controls, product code GWG).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on April 21, 1997, 175 days after receiving the submission on October 28, 1996.
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 | K964281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1996 |
| Decision Date | April 21, 1997 |
| Days to Decision | 175 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). |