ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE— 510(k) K042796

Name: FDA 510(k) clearance K042796
Creator: U.S. Food and Drug Administration
Published: 2004-11-05

Substantially Equivalent

Coapt Systems, Inc.

FDA 510(k) clearance K042796 for ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE, Substantially Equivalent on 2004-11-05. Applicant: Coapt Systems, Inc.. Device class: 2.

Clearance details

Applicant: Coapt Systems, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2004-10-07
Decision date: 2004-11-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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 →

Recalls naming K042796

K-number listed on FDA's recall record

Z-2294-2016 — Endotine Transbleph 3.5 (CFD-080-0167)Class II·Terminated·MicroAire Surgical Instruments, LLC·20160506

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042796.

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