FDA Device Intelligence
Home › NORTHGATE TECHNOLOGIES INC. › Lithotripsy Probe 1.9FR 120cm

Lithotripsy Probe 1.9FR 120cm

NORTHGATE TECHNOLOGIES INC. · Model 9-196-12 · UDI-DI 00817183020165

FFK Prescription
1
510(k) clearances
438
Adverse events (9 deaths)
21
Recalls
34
Facilities

Description

1.9FR 120cm Lithotripsy Probe for use with Autolith Lithotripters

Recalls

DateFirmReason
2022-04-13Northgate Technologies, Inc.Product labeled incorrectly.
2021-10-25Northgate Technologies, Inc.The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
2020-03-10Northgate Technologies, Inc.As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

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.