OR340 Intraoperative Ultrasound Biopsy Needle Guid
FDA 510(k) K913987 · Codman & Shurtleff, Inc.
510(k) numberK913987
Submission
- Device name
- OR340 Intraoperative Ultrasound Biopsy Needle Guid
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- September 5, 1991
- Decision date
- April 13, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was OR340 Intraoperative Ultrasound Biopsy Needle Guid cleared by the FDA?
OR340 Intraoperative Ultrasound Biopsy Needle Guid (K913987) received a 510(k) decision of Substantially Equivalent on April 13, 1992, 221 days after the submission was received.
What is the product code of K913987?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.