BIRCOLL BALLOON DISSECTOR
FDA 510(k) clearance K984448 · decided 1999-01-28
Clearance details
- K-number
- K984448
- Device name
- BIRCOLL BALLOON DISSECTOR
- Applicant
- Wells Johnson Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-14
- Decision date
- 1999-01-28
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- FZW
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (K080158) | Lb Medical LLC | 2008-05-02 |
| SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (K972109) | General Surgical Innovations | 1997-11-14 |
| AESCULAP SKIN GRAFT MESHER (K936186) | Aesculap, Inc. | 1994-03-10 |
| INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (K904265) | Inamed Development Co. | 1991-03-06 |
| SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER (K902349) | Surgitek | 1990-09-05 |
| MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (K883303) | Mentor Corp. | 1988-08-26 |
| CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (K874276) | Cox-Uphuff Intl. | 1987-12-02 |
Recalls involving this device
No recalls on record reference this clearance.