FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TISSUE EXPANDER
K Number: K840464
·
Decision Mar 12, 1984
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
29
Review Days
38
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Basic Information
- Device Name
- TISSUE EXPANDER
- K Number
- K840464
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Surgitek
- Date Received
- February 3, 1984
- Decision Date
- March 12, 1984
- Product Code
- LCJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | FDA unclassified | Unknown |
Similar 510(k) Clearances
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Mentor CPX 4 PLUS Enhance Breast Tissue Expander
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MENTOR CPX4 PLUS Enhance Breast Tissue Expander
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Motiva Flora SmoothSilk Tissue Expander
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AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
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 |