R-GROUP INTL. ONE WALL PUNCTURE NEEDLE— 510(k) K913267

Substantially Equivalent

R-Group Intl.

FDA 510(k) clearance K913267 for R-GROUP INTL. ONE WALL PUNCTURE NEEDLE, Substantially Equivalent on 1992-06-05. Applicant: R-Group Intl..

Clearance details

Applicant: R-Group Intl.
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 1991-07-23
Decision date: 1992-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.