FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILIZED OMNI GEL
K Number: K872519
·
Decision Aug 3, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
8
Applicant Total
6
Review Days
39
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Basic Information
- Device Name
- STERILIZED OMNI GEL
- K Number
- K872519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Echo Ultrasound
- Date Received
- June 25, 1987
- Decision Date
- August 3, 1987
- Product Code
- JOT
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JOT | Electrode, Gel, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Echo Ultrasound
| K Number | Device Name | ||
|---|---|---|---|
| K924054 | PHONOCARDIOGRAPH | Jan 22, 1993 | Substantially Equivalent |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Sep 19, 1990 | Substantially Equivalent |
| K893225 | COUPLANT WARMING DEVICE | Oct 12, 1989 | Substantially Equivalent |
| K844034 | SONOCARE | Jan 23, 1985 | Substantially Equivalent |
| K844120 | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | Jan 23, 1985 | Substantially Equivalent |