K953913 is an FDA 510(k) clearance for the OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES. This device is classified as a Arthroscope (Class II - Special Controls, product code HRX).
Submitted by Optus, Inc. (Denver, US). The FDA issued a Cleared decision on January 22, 1996, 154 days after receiving the submission on August 21, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.1100. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K953913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1995 |
| Decision Date | January 22, 1996 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HRX — Arthroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.1100 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |