ACUFEX TAG BIOABSORBABLE ANCHORS— 510(k) K961555

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K961555 for ACUFEX TAG BIOABSORBABLE ANCHORS, Substantially Equivalent on 1996-07-10. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 1996-04-22
Decision date: 1996-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.