FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
K Number: K902349
·
Decision Sep 5, 1990
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
7
Applicant Total
29
Review Days
103
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Basic Information
- Device Name
- SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
- K Number
- K902349
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgitek
- Date Received
- May 25, 1990
- Decision Date
- September 5, 1990
- 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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BIRCOLL BALLOON DISSECTOR
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SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
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AESCULAP SKIN GRAFT MESHER
FDA 510(k)
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INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Surgitek
| K Number | Device Name | ||
|---|---|---|---|
| K946296 | QUADRA-COIL URETERAL STENT | Mar 6, 1995 | Substantially Equivalent |
| K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM | Feb 7, 1995 | Substantially Equivalent |
| K943491 | RIGHT ANGLE UROLOGIC LASER FIBER | Aug 5, 1994 | Substantially Equivalent |
| K941952 | SURGITEK INFUSER | May 24, 1994 | Substantially Equivalent |
| K933261 | GRASPING FORCEPS | Jan 11, 1994 | Substantially Equivalent |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | Jan 11, 1994 | Substantially Equivalent |
| K930733 | URETERAL STENT | Jul 23, 1993 | Substantially Equivalent |
| K930483 | URETERAL CATHETER | Jul 16, 1993 | Unknown |
| K926344 | HYDROPHILIC COATED GUIDEWIRE | Mar 5, 1993 | Substantially Equivalent |
| K920451 | ENDOTEK ULTRA SYSTEM | Sep 17, 1992 | Substantially Equivalent |