K843282 is an FDA 510(k) clearance for the UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC. This device is classified as a Forceps, Biopsy, Bronchoscope (non-rigid) (Class II - Special Controls, product code BWH).
Submitted by Rush Hampton Industries (Sanford, US). The FDA issued a Cleared decision on October 22, 1984, 63 days after receiving the submission on August 20, 1984.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. 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 | K843282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1984 |
| Decision Date | October 22, 1984 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | BWH — Forceps, Biopsy, Bronchoscope (non-rigid) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| 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). |