HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
FDA 510(k) clearance K011657 · decided 2001-08-27
Clearance details
- K-number
- K011657
- Device name
- HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-29
- Decision date
- 2001-08-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mt. Vernon, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring recall (Z-0759-2013) | Varian Medical Systems, Inc. | 2013-01-31 |
| Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tan recall (Z-0760-2013) | Varian Medical Systems, Inc. | 2013-01-31 |