K000932 is an FDA 510(k) clearance for the ARACHNOPHLEBECTOMY NEEDLE. This device is classified as a Stylet, Surgical, General & Plastic Surgery (Class I - General Controls, product code GAH).
Submitted by Advanced Medical Products, Inc. (Clarksville, US). The FDA issued a Cleared decision on May 17, 2000, 55 days after receiving the submission on March 23, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K000932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2000 |
| Decision Date | May 17, 2000 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAH — Stylet, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |