inforMED
OTJClass II

Laparoscopic Single Port Access Device

Gastroenterology, Urology · 21 CFR 876.1500

A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

MDR events18All time
Recalls0All time
Registered firms11Currently listed
510(k) clearances11All time

Recent MDR events

18 adverse event reports on file

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Event type breakdown

Malfunction17
Injury1

Most-reported manufacturers

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Transenterix Inc.8Transenterix, Inc.6Advanced Surgical Concepts, Ltd1Fortimedix Surgical B.v.1Microline Surgical, Inc.1Unknown1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

11 firms currently registered for this product code

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510(k) clearances

11 clearances for this product code

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