FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Natrelle 133 Plus MICROCELL Tissue Expander
K Number: K180826
·
Decision Dec 21, 2018
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
6
Review Days
266
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Natrelle 133 Plus MICROCELL Tissue Expander
- K Number
- K180826
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allergan
- Date Received
- March 30, 2018
- Decision Date
- December 21, 2018
- 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
Other 510(k) clearances with the same product code (LCJ), ordered by most recent decision date.
Natrelle 133S Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
FDA 510(k)
FDA Unclassified
·Unknown
Mentor CPX 4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
MENTOR CPX4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
Motiva Flora SmoothSilk Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Allergan
| K Number | Device Name | ||
|---|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | Jun 2, 2021 | Substantially Equivalent |
| K193589 | TrueTear Intranasal Tear Neurostimulator | Aug 31, 2020 | Substantially Equivalent |
| K182054 | Natrelle 133S Tissue Expander | Aug 29, 2018 | Substantially Equivalent |
| DEN170086 | TrueTear Intranasal Tear Neurostimulator | May 17, 2018 | Unknown |
| K123128 | SERI SURGICAL SCAFFOLD | Apr 25, 2013 | Substantially Equivalent |