K873933 is an FDA 510(k) clearance for the RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM. This device is classified as a Instrument, Microsurgical (Class I - General Controls, product code GZX).
Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on December 17, 1987, 83 days after receiving the submission on September 25, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4525.
| 510(k) Number | K873933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1987 |
| Decision Date | December 17, 1987 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GZX — Instrument, Microsurgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4525 |