FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AART CALF IMPLANT
K Number: K022511
·
Decision Aug 26, 2002
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
44
Applicant Total
10
Review Days
27
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Basic Information
- Device Name
- AART CALF IMPLANT
- K Number
- K022511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesthetic and Reconstructive Technologies, Inc.
- Date Received
- July 30, 2002
- Decision Date
- August 26, 2002
- Product Code
- MIB
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MIB), ordered by most recent decision date.
MISTI Silicone Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pre-Formed Silicone Block
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FDA Class 2
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ShiNeo Silicone Implant
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FDA Class 2
·Ear, Nose, Throat
AugMENTA Penile Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pre-Formed Penile Silicone Block
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BioSiCar Silicone Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Aesthetic and Reconstructive Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023678 | DIMISIL SCAR GEL | Jan 23, 2003 | Substantially Equivalent |
| K022306 | AART SILICONE TUBING | Oct 10, 2002 | Substantially Equivalent |
| K022223 | AART SILICONE SHEETING | Aug 8, 2002 | Substantially Equivalent |
| K021820 | AART SILICONE CARVING BLOCK | Jul 16, 2002 | Substantially Equivalent |
| K021839 | AART GLUTEAL IMPLANT | Jul 16, 2002 | Substantially Equivalent |
| K021337 | AART PECTORALIS IMPLANT | Jul 3, 2002 | Substantially Equivalent |
| K021417 | AART CHIN IMPLANT | Jul 2, 2002 | Substantially Equivalent |
| K021419 | AART MALAR IMPLANT | Jul 2, 2002 | Substantially Equivalent |
| K021418 | AART NASAL IMPLANT | Jul 2, 2002 | Substantially Equivalent |