RAPID STRAND RX
FDA 510(k) clearance K063177 · decided 2006-11-30
Clearance details
- K-number
- K063177
- Device name
- RAPID STRAND RX
- Applicant
- Oncura, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-19
- Decision date
- 2006-11-30
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KXK
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- North Brunswick, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spac recall (Z-0266-2012) | Medi-Physics Inc. dba GE Healthcare | 2011-11-22 |