FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REPROCESSED COLD BIOPSY FORCEPS
K Number: K042648
·
Decision Jul 20, 2005
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
64
Review Days
295
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Basic Information
- Device Name
- REPROCESSED COLD BIOPSY FORCEPS
- K Number
- K042648
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterilmed, Inc.
- Date Received
- September 28, 2004
- Decision Date
- July 20, 2005
- Product Code
- NON
- 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 |
|---|---|---|---|
| NON | Forceps, Biopsy, Non-Electric, Reprocessed | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NON), ordered by most recent decision date.
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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