K940222 is an FDA 510(k) clearance for the SMITH AND NEPHEW SPINE DEFLECTING FORCEPS. This device is classified as a Arthroscope (Class II - Special Controls, product code HRX).
Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on June 29, 1994, 162 days after receiving the submission on January 18, 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 | K940222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | January 18, 1994 |
| Decision Date | June 29, 1994 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| 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). |