AUTOLITH TOUCH; URO TOUCH— 510(k) K130368
Substantially EquivalentNorthgate Technologies, Inc.
FDA 510(k) clearance K130368 for AUTOLITH TOUCH; URO TOUCH, Substantially Equivalent on 2013-11-15. Applicant: Northgate Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Northgate Technologies, Inc.
- Product code
- Code FFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elgin, IL, US
Recent devices under product code FFK
view allMore clearances from Northgate Technologies, Inc.
view allRecalls naming K130368
K-number listed on FDA's recall record- Z-1235-2022 — AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
- Z-0333-2022 — Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
- Z-1883-2020 — Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Z-1884-2020 — AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130368.
Data sourced from openFDA. This site is unofficial and independent of the FDA.