FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER
K Number: K874276
·
Decision Dec 2, 1987
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
7
Applicant Total
11
Review Days
43
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Basic Information
- Device Name
- CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER
- K Number
- K874276
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cox-Uphuff Intl.
- Date Received
- October 20, 1987
- Decision Date
- December 2, 1987
- Product Code
- FZW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZW | Expander, Surgical, Skin Graft | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZW), ordered by most recent decision date.
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
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AESCULAP SKIN GRAFT MESHER
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INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
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SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
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Other Clearances by Cox-Uphuff Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K874342 | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | Nov 13, 1987 | Substantially Equivalent |
| K873470 | TEMPLATE | Sep 8, 1987 | Substantially Equivalent |
| K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | May 22, 1987 | Substantially Equivalent |
| K871200 | CUI NASAL SEPTUM BUTTON | Apr 15, 1987 | Substantially Equivalent |
| K865033 | BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER | Jan 12, 1987 | Substantially Equivalent |
| K854339 | CUI CHIN SIZER | Nov 15, 1985 | Substantially Equivalent |
| K853945 | CUI RHINOPLASTY IMPLANTS | Oct 18, 1985 | Substantially Equivalent |
| K831566 | CUI MAMMARY PROTHESIS SIZER | Aug 12, 1983 | Substantially Equivalent |
| K813394 | DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM | Jan 22, 1982 | Substantially Equivalent |
| K802214 | COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM | Oct 23, 1980 | Substantially Equivalent |