FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
K Number: K022751
·
Decision Nov 4, 2002
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
45
Applicant Total
5
Review Days
77
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Basic Information
- Device Name
- REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
- K Number
- K022751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Device Services
- Date Received
- August 19, 2002
- Decision Date
- November 4, 2002
- Product Code
- KGE
- 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 |
|---|---|---|---|
| KGE | Forceps, Biopsy, Electric | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medical Device Services
| K Number | Device Name | ||
|---|---|---|---|
| K022753 | REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS | Nov 14, 2002 | Substantially Equivalent |
| K022743 | REPROCESSED DISPOSABLE TROCARS | Oct 9, 2002 | Substantially Equivalent |
| K022748 | REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS | Oct 9, 2002 | Substantially Equivalent |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Sep 18, 2002 | Substantially Equivalent |