FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIFLO FILTERED INSUFFLATION TUBING
K Number: K930508
·
Decision Jun 25, 1993
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
3
Review Days
144
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Basic Information
- Device Name
- HIFLO FILTERED INSUFFLATION TUBING
- K Number
- K930508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- W. J. Medical Instruments, Inc.
- Date Received
- February 1, 1993
- Decision Date
- June 25, 1993
- Product Code
- FCX
- 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 |
|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | FDA class 2 | Gastroenterology, Urology |
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