K911588 is an FDA 510(k) clearance for the BRANDT ESOPHAGEAL CYTOLOGY BALLOON. This device is classified as a Esophagoscope (flexible Or Rigid) (Class II - Special Controls, product code EOX).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on November 18, 1992, 589 days after receiving the submission on April 9, 1991.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4710. 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 | K911588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1991 |
| Decision Date | November 18, 1992 |
| Days to Decision | 589 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EOX — Esophagoscope (flexible Or Rigid) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4710 |
| 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). |