K921642 is an FDA 510(k) clearance for the AMSEN DOUBLE-ENDED FORAMINAL PROBE. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Advanced Med/Surg, Inc. (Hayward, US). The FDA issued a Cleared decision on June 3, 1992, 58 days after receiving the submission on April 6, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K921642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1992 |
| Decision Date | June 03, 1992 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LXH — Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |