K943943 is an FDA 510(k) clearance for the TRANSTIBIAL ACL DISPOSABLES KIT. This device is classified as a Arthroscope (Class II - Special Controls, product code HRX).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 20, 1994, 131 days after receiving the submission on August 11, 1994.
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 | K943943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1994 |
| Decision Date | December 20, 1994 |
| Days to Decision | 131 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). |