MANAN ACCURA NEEDLE— 510(k) K974741
Substantially EquivalentMedical Device Technologies, Inc.
FDA 510(k) clearance K974741 for MANAN ACCURA NEEDLE, Substantially Equivalent on 1998-01-08. Applicant: Medical Device Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Device Technologies, Inc.
- Product code
- Code GAA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainsville, FL, US
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- K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
Adverse events under product code GAA
product code GAA- Malfunction
- 834
- Total
- 834
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.