BMC RF CANNULA
FDA 510(k) clearance K972846 · decided 1998-07-17
Clearance details
- K-number
- K972846
- Device name
- BMC RF CANNULA
- Applicant
- Baylis Medical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-01
- Decision date
- 1998-07-17
- Days to decision
- 350 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 m recall (Z-0850-2014) | Kimberly-Clark Corporation | 2014-01-28 |
| BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Leng recall (Z-0879-2013) | Baylis Medical Company Inc. | 2013-02-26 |