FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ALLOX2 TISSUE EXPANDERS
K Number: K140383
·
Decision Oct 28, 2014
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
12
Review Days
256
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Basic Information
- Device Name
- ALLOX2 TISSUE EXPANDERS
- K Number
- K140383
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Specialty Surgical Products, Inc.
- Date Received
- February 14, 2014
- Decision Date
- October 28, 2014
- 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 |
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Other Clearances by Specialty Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | Feb 12, 1999 | Substantially Equivalent |
| K983015 | VIRILIS PENILE PROSTHESIS | Feb 5, 1999 | Substantially Equivalent |
| K982258 | MAMMARY SIZER | Sep 8, 1998 | Substantially Equivalent |
| K982065 | STERILE SILICONE EXTERNAL WOUND COVER | Aug 12, 1998 | Substantially Equivalent |
| K982067 | MAGNETIC PORT SILICONE TISSUE EXPANDER | Jul 13, 1998 | Substantially Equivalent |
| K974653 | SILICONE ELASTOMER SHEETING | Mar 13, 1998 | Substantially Equivalent |
| K974654 | SILICONE BLOCKS | Feb 24, 1998 | Substantially Equivalent |
| K974209 | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | Feb 6, 1998 | Substantially Equivalent |
| K973656 | DISPOSABLE SILICONE EPISTAXIS CATHETER | Nov 18, 1997 | Substantially Equivalent |
| K973082 | VENTRAL WALL DEFECT REDUCTION SILO | Nov 4, 1997 | Substantially Equivalent |