FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APEX
K Number: K141158
·
Decision Nov 26, 2014
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
7
Review Days
205
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Basic Information
- Device Name
- APEX
- K Number
- K141158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Incontrol Medical, LLC
- Date Received
- May 5, 2014
- Decision Date
- November 26, 2014
- Product Code
- KPI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Incontrol Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K182022 | ApexMV | Mar 15, 2019 | Unknown |
| K150183 | ApexM | Apr 9, 2015 | Substantially Equivalent |
| K150180 | InTone | Mar 16, 2015 | Substantially Equivalent |
| K134020 | INTONEMV | Feb 25, 2014 | Substantially Equivalent |
| K133826 | INTONEMV | Jan 6, 2014 | Substantially Equivalent |
| K110179 | INCONTROL | Feb 22, 2012 | Substantially Equivalent |