FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K Number: K163050
·
Decision Oct 25, 2017
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
32
Review Days
358
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Basic Information
- Device Name
- Advance Medical Designs, Inc. Sterile Ultrasound Gel
- K Number
- K163050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advance Medical Designs, Inc.
- Date Received
- November 1, 2016
- Decision Date
- October 25, 2017
- Product Code
- MUI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Sterile and Non-Sterile Ultrasound Gels
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|---|---|---|---|
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| K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | Sep 18, 2001 | Substantially Equivalent |
| K011422 | SURGICAL DRAPES | Jul 10, 2001 | Substantially Equivalent |
| K003670 | PATIENT DRAPE, SURGICAL | Jan 26, 2001 | Substantially Equivalent |
| K911884 | ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES | Jul 5, 1994 | Substantially Equivalent |
| K925115 | AMD DENTIST AND HYGIENIST KITS | Jul 5, 1994 | Substantially Equivalent |
| K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | Dec 11, 1992 | Substantially Equivalent |
| K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE | Sep 16, 1991 | Substantially Equivalent |