FDA Device Intelligence
Home › ARKIS BIOSCIENCES INC. › Precision Tunneler - Large

Precision Tunneler - Large

ARKIS BIOSCIENCES INC. · Model 41.020.503 · UDI-DI 00866614000177

GYK Prescription
10
510(k) clearances
15
Adverse events
1
Recalls
21
Facilities

Description

The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when implanting a ventricular shunting system in patients with normal skin.

Recalls

DateFirmReason
2010-12-22Integra LifeSciences Corp.Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.