FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
K Number: K940903
·
Decision Apr 14, 1994
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
0
Applicant Total
4
Review Days
49
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Basic Information
- Device Name
- TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
- K Number
- K940903
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Insights, Inc.
- Date Received
- February 24, 1994
- Decision Date
- April 14, 1994
- Product Code
- KBM
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KBM | Dissector, Tonsil | FDA class 1 | Ear, Nose, Throat |