DeviceClearance

ACUFEX T-BAR— 510(k) K925573

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K925573 for ACUFEX T-BAR, Substantially Equivalent on 1993-05-05. Applicant: Acufex Microsurgical, Inc.. Device class: 2.

Clearance details

Applicant
Acufex Microsurgical, Inc.
Product code
Code HRX
Device class
Class 2
Regulation
21 CFR 888.1100
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mansfield, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Acufex Microsurgical, Inc.

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Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

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 →

Recalls naming K925573

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925573.

Data sourced from openFDA. This site is unofficial and independent of the FDA.