FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROLOGIC TUBE HOLDER
K Number: K810787
·
Decision Mar 31, 1981
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
9
Applicant Total
6
Review Days
8
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Basic Information
- Device Name
- UROLOGIC TUBE HOLDER
- K Number
- K810787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- The Urology Group
- Date Received
- March 23, 1981
- Decision Date
- March 31, 1981
- Product Code
- OCV
- 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 |
|---|---|---|---|
| OCV | Endoscope Holder | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by The Urology Group
| K Number | Device Name | ||
|---|---|---|---|
| K831703 | COVERUPS | Jan 3, 1984 | Substantially Equivalent |
| K831489 | SURGICAL TUBE HOLDER | Dec 12, 1983 | Substantially Equivalent |
| K810739 | SUCTION WOUND DRAINAGE DEVICE | Jun 26, 1981 | Substantially Equivalent |
| K810788 | SURGICAL TUBE HOLDER | Apr 17, 1981 | Substantially Equivalent |
| K801629 | COVER-ALL MALE INCONTINENCE DEVICE | Aug 12, 1980 | Substantially Equivalent |