FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
K Number: K042594
·
Decision Jan 25, 2005
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
33
Review Days
124
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Basic Information
- Device Name
- VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
- K Number
- K042594
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vanguard Medical Concepts, Inc.
- Date Received
- September 23, 2004
- Decision Date
- January 25, 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.
REPROCESSED COLD BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Vanguard Medical Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053051 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Dec 22, 2005 | Substantially Equivalent |
| K051616 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Sep 6, 2005 | Substantially Equivalent |
| K051180 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Jul 22, 2005 | Substantially Equivalent |
| K051043 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Jun 6, 2005 | Substantially Equivalent |
| K050763 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Jun 1, 2005 | Substantially Equivalent |
| K043198 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | May 27, 2005 | Substantially Equivalent |
| K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | Apr 8, 2005 | Substantially Equivalent |
| K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES | Mar 31, 2005 | Substantially Equivalent |
| K043225 | VANGUARD REPROCESSED ULTRASONIC SCALPEL | Mar 22, 2005 | Substantially Equivalent |
| K043315 | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL | Mar 22, 2005 | Substantially Equivalent |