FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EndyGel
K Number: K161715
·
Decision Feb 7, 2017
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
8
Review Days
231
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Basic Information
- Device Name
- EndyGel
- K Number
- K161715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endymed Medical, Ltd.
- Date Received
- June 21, 2016
- Decision Date
- February 7, 2017
- Product Code
- GYB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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Other Clearances by Endymed Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242996 | EndyMed PRO MAX | Jun 10, 2025 | Substantially Equivalent |
| K222369 | PURE Laser | Oct 7, 2022 | Substantially Equivalent |
| K161199 | EndyMed Contour Handpiece | Aug 1, 2016 | Substantially Equivalent |
| DEN150005 | Newa Skin Therapy System | Dec 18, 2015 | Unknown |
| K130501 | INTENSIF | Mar 13, 2014 | Substantially Equivalent |
| K120513 | GLOW BY ENDYMED | May 8, 2012 | Substantially Equivalent |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Feb 17, 2011 | Substantially Equivalent |