BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
FDA 510(k) clearance K961505 · decided 1996-07-18
Clearance details
- K-number
- K961505
- Device name
- BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
- Applicant
- Conmedcorp
- Decision
- Substantially Equivalent
- Date received
- 1996-04-19
- Decision date
- 1996-07-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dayton, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 1 S recall (Z-2276-2010) | ConMed Electrosurgery | 2010-08-25 |
| ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 1 recall (Z-2277-2010) | ConMed Electrosurgery | 2010-08-25 |
| ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 1 recall (Z-2278-2010) | ConMed Electrosurgery | 2010-08-25 |