SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
FDA 510(k) clearance K972109 · decided 1997-11-14
Clearance details
- K-number
- K972109
- Device name
- SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
- Applicant
- General Surgical Innovations
- Decision
- Substantially Equivalent
- Date received
- 1997-06-05
- Decision date
- 1997-11-14
- Days to decision
- 162 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
- Cupertino, CA, 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 |
| BIRCOLL BALLOON DISSECTOR (K984448) | Wells Johnson Co. | 1999-01-28 |
| 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.