Product code FZW
- Device name
- Expander, Surgical, Skin Graft
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080158 | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM | Lb Medical LLC | 2008-05-02 |
| K984448 | BIRCOLL BALLOON DISSECTOR | Wells Johnson Co. | 1999-01-28 |
| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | General Surgical Innovations | 1997-11-14 |
| K936186 | AESCULAP SKIN GRAFT MESHER | Aesculap, Inc. | 1994-03-10 |
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | Inamed Development Co. | 1991-03-06 |
| K902349 | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER | Surgitek | 1990-09-05 |
| K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER | Mentor Corp. | 1988-08-26 |
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Cox-Uphuff Intl. | 1987-12-02 |
Related GUDID Devices#
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|---|---|---|---|
| 07445161009586 | Motiva® Inflatable Balloon | Establishment Labs S.A. | 2025-06-06 |
| 07445161009579 | Motiva® Inflatable Balloon | Establishment Labs S.A. | 2025-06-06 |
| 07445161009494 | Motiva® Inflatable Balloon | Establishment Labs S.A. | 2025-06-06 |
| 04049197024709 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-10-02 |
| 04049197024693 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-10-02 |
| 04049197024686 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-10-02 |
| 00810006780185 | Mesh Ex | EXSURCO MEDICAL, INC. | 2024-03-20 |
| 00810006780154 | Mesh Ex | EXSURCO MEDICAL, INC. | 2024-03-20 |
| 00810006780147 | Mesh Ex | EXSURCO MEDICAL, INC. | 2024-03-20 |
| 00810006780130 | Mesh Ex | EXSURCO MEDICAL, INC. | 2024-03-20 |
| 00810006780123 | Mesh Ex | EXSURCO MEDICAL, INC. | 2024-03-20 |
| 05033955120504 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-30 |
| 05033955099435 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-13 |
| 05033955099459 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-13 |
| 05033955099442 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-13 |
| 05033955099428 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-13 |
| 05033955099404 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-13 |
| 05033955022037 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-02 |
| 05033955022013 | Swann Morton Ltd. | SWANN-MORTON LIMITED | 2022-05-02 |
| 00889024375482 | Dermacarriers | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2021-11-01 |
| 00889024372580 | MeshgraftTM II Tissue Expansion System | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2020-09-23 |
| 00889024372566 | MeshgraftTM II Tissue Expansion System | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2020-09-23 |
| 00889024372559 | MeshgraftTM II Tissue Expansion System | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | 2020-09-23 |
| 04038653085194 | AESCULAP | Aesculap AG | 2020-05-08 |
| 04038653085170 | AESCULAP | Aesculap AG | 2020-05-08 |
| 04038653085156 | AESCULAP | Aesculap AG | 2020-05-08 |
| 10381780277910 | Integra® Padgett® Dermatomes | INTEGRA LIFESCIENCES CORPORATION | 2018-04-19 |
| 10381780277934 | Integra® Padgett® | INTEGRA LIFESCIENCES CORPORATION | 2018-04-19 |
| 10381780277927 | Integra® Padgett® | INTEGRA LIFESCIENCES CORPORATION | 2018-04-19 |
| 00885554018288 | NA | Smith & Nephew, Inc. | 2016-08-24 |