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SOLAR Anorectal Manometry Catheter

Laborie Medical Technologies Corp. · Model K1210AC-L-2212 · UDI-DI 00627825014830

KLA Prescription
1
510(k) clearances
7
Adverse events
1
Recalls
15
Facilities

Description

SOLAR Anorectal Manometry Catheter

Recalls

DateFirmReason
2006-04-06Medtronic Gastroenterology / UrologyMislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is

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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.