Cui, Versafil(Tm), Ste(Tm) Tissue Expander
FDA 510(k) K874276 · Cox-Uphuff Intl.
510(k) numberK874276
Submission
- Device name
- Cui, Versafil(Tm), Ste(Tm) Tissue Expander
- Applicant
- Cox-Uphuff Intl.
Santa Barbara, CA, US - Received
- October 20, 1987
- Decision date
- December 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZW – Expander, Surgical, Skin Graft
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080158 | LB Medical Inflatable Tissue Elevator/Expander SystemFZW · Traditional | Lb Medical LLC | 05/02/2008SE |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | Wells Johnson Co. | 01/28/1999SE |
| K972109 | Spacemaker Surgicalballoon Dissector/ExpanderFZW · Traditional | General Surgical Innovations | 11/14/1997SE |
| K936186 | Aesculap Skin Graft MesherFZW · Traditional | Aesculap, Inc. | 03/10/1994SE |
| K904265 | Inamed Ruiz-Cohen Intraoperative Tissue ExpanderFZW · Traditional | Inamed Development Co. | 03/06/1991SE |
| K902349 | Surgitek Intra-Span Intraoperative Tissue ExpanderFZW · Traditional | Surgitek | 09/05/1990SE |
| K883303 | Mentor Rapid-Span (TM) Tissue ExpanderFZW · Traditional | Mentor Corp. | 08/26/1988SE |
More from Mentor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K874342 | Ligature Carrier/Packer, HydroxylapatiteGEJ · Traditional | 11/13/1987SE |
| K873470 | TemplateFTY · Traditional | 09/08/1987SE |
| K865056 | Cui Tissue Expander Versafil(Tm) Tissue ExpanderLCJ · Traditional | 05/22/1987SE |
| K871200 | Cui Nasal Septum ButtonLFB · Traditional | 04/15/1987SE |
| K865033 | Breast Prosthesis (Non & Inflatable) Skin ExpanderLCJ · Traditional | 01/12/1987SE |
| K854339 | Cui Chin Sizer · Traditional | 11/15/1985SE |
| K853945 | Cui Rhinoplasty ImplantsFZE · Traditional | 10/18/1985SE |
| K831566 | Cui Mammary Prothesis SizerMRD · Traditional | 08/12/1983SE |
| K813394 | DS-7 Closed Wound Suction Drain SystemGCX · Traditional | 01/22/1982SE |
| K802214 | Cos-Uphoff Int'L DS-5 Drainage SystemGCY · Traditional | 10/23/1980SE |
Questions and answers
When was Cui, Versafil(Tm), Ste(Tm) Tissue Expander cleared by the FDA?
Cui, Versafil(Tm), Ste(Tm) Tissue Expander (K874276) received a 510(k) decision of Substantially Equivalent on December 2, 1987, 43 days after the submission was received.
What is the product code of K874276?
The FDA product code is FZW – Expander, Surgical, Skin Graft, a Class I (low risk) device regulated under 21 CFR 878.4800.