510(k) K913987
K913987 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID". The FDA issued a decision of Substantially Equivalent on April 13, 1992. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 1992
- Date Received
- September 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assembly, Tube Housing, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1760
- Review Panel
- RA
- Submission Type