FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
HAND PACK
K Number: K914934
·
Decision Jan 21, 1993
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
444
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Basic Information
- Device Name
- HAND PACK
- K Number
- K914934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Westmark Hospital Supplies
- Date Received
- November 4, 1991
- Decision Date
- January 21, 1993
- Product Code
- KDO
- 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 |
|---|---|---|---|
| KDO | Rongeur, Cystoscopic, Hot | FDA class 2 | Gastroenterology, Urology |