FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY FORCEPS (NON-RIGID)
K Number: K901339
·
Decision Jun 11, 1990
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
353
Applicant Total
23
Review Days
81
Basic Information
- Device Name
- BIOPSY FORCEPS (NON-RIGID)
- K Number
- K901339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- APPLIED MEDICAL TECHNOLOGIES
- Date Received
- March 22, 1990
- Decision Date
- June 11, 1990
- Product Code
- KNW
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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| K945618 | GASTROINTESTINAL TUBES & ACCESSORIES | Oct 12, 1995 | Substantially Equivalent |
| K946140 | PRG BUTTON | Aug 28, 1995 | Substantially Equivalent |
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