FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
K Number: K043253
·
Decision Apr 8, 2005
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
33
Review Days
135
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Basic Information
- Device Name
- VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
- K Number
- K043253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vanguard Medical Concepts, Inc.
- Date Received
- November 24, 2004
- Decision Date
- April 8, 2005
- Product Code
- NLM
- 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 |
|---|---|---|---|
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | FDA class 2 | Gastroenterology, Urology |
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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 |
| 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 |
| K040751 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Mar 10, 2005 | Substantially Equivalent |