NMLClass II

Catheter, Biliary, Reprocessed

Gastroenterology, Urology · 21 CFR 876.5010

same as "FGE" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

MDR events1All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances1All time

Recent MDR events

1 adverse event reports on file

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TANDEM RX CANNULAJul 14, 2009
InjuryBoston Scientific Corporation3005099803-2009-03307

Event type breakdown

Injury1

Most-reported manufacturers

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Boston Scientific Corporation1

Recalls

1 recall events for this product code

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Sterilmed Inc
TerminatedJan 13, 2009
Guidewires - Endoscopic (Jag Wires)
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0558-2009 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

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No registered firms found for this product code.

510(k) clearances

1 clearances for this product code

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Sterilmed, Inc.Apr 29, 2002
K012556 · REPROCESSED GUIDEWIRES