OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID— 510(k) K913987
Substantially EquivalentCodman & Shurtleff, Inc.
FDA 510(k) clearance K913987 for OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID, Substantially Equivalent on 1992-04-13. Applicant: Codman & Shurtleff, Inc.. Device class: 1.
Clearance details
- Applicant
- Codman & Shurtleff, Inc.
- Product code
- Code ITY
- Device class
- Class 1
- Regulation
- 21 CFR 892.1760
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Randolph, MA, US
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Adverse events under product code ITY
product code ITY- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.