REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS— 510(k) K032973
Substantially EquivalentVanguard Medical Concepts, Inc.
FDA 510(k) clearance K032973 for REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS, Substantially Equivalent on 2003-12-18. Applicant: Vanguard Medical Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Vanguard Medical Concepts, Inc.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lubbock, TX, US
Recent devices under product code GDW
view allMore clearances from Vanguard Medical Concepts, Inc.
view all- K053051 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051616 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051180 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051043 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.