K936207 is an FDA 510(k) clearance for the ENDO-NEEDLE INSTRUMENT. This device is classified as a Needle, Aspiration And Injection, Reusable (Class I - General Controls, product code GDM).
Submitted by Gerard Medical, Inc. (Charlton, US). The FDA issued a Cleared decision on June 16, 1994, 169 days after receiving the submission on December 29, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K936207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1993 |
| Decision Date | June 16, 1994 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDM — Needle, Aspiration And Injection, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |