K913987 is an FDA 510(k) clearance for the OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID. This device is classified as a Assembly, Tube Housing, X-ray, Diagnostic (Class I - General Controls, product code ITY).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on April 13, 1992, 221 days after receiving the submission on September 5, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1760.
| 510(k) Number | K913987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1991 |
| Decision Date | April 13, 1992 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | ITY - Assembly, Tube Housing, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1760 |