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GEN2

SURGIX MEDICAL LLC · Model G2OB1595 · UDI-DI 00840343718312

GCC Prescription
5
510(k) clearances
74
Adverse events (10 deaths)
5
Recalls
101
Facilities

Description

FEMALE CATHERER 14F 6 1/8"

Recalls

DateFirmReason
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
2013-07-31DePuy Spine, Inc.Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.