LABORIE MEDICAL TECHNOLOGIES CORP.

FDA Device Registration & Listing · Portsmouth, NH, US · Registration 3017448360

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017448360
FEI Number
3017448360
Entity Name
LABORIE MEDICAL TECHNOLOGIES CORP.
City/State/Country
Portsmouth, NH, US
Establishment Address
180 International Drive, Portsmouth, NH 03801, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Laborie Medical Technologies Corp. (Owner Number: 10079684)
Owner / Operator Contact Address
180 International Drive, Portsmouth, NH 03801, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K950016
PMA Number
N/A

All Registered Proprietary Names

injeTAK Adjustable Tip Needle Tube for Vaginal Sensor UROSTYM Biofeedback Probes Tube for Anal Sensor Injetak UROSTYM Biofeedback and Stimulation Probes GI Catheters (electrical) Solar Compact Ohmega Solar GI with MMP Plus GI System (Electrical) Solar GI 8-Channel Perfusion Set 8-Channel Radial Anorectal Catheter 4-Channel Radial Anorectal Catheter 4-Channel Radial ARM Catheter Ano-rectal Manometry Option (ARM) 4-Channel Perfusion Set Solar GI with Neuro Module I-LIST HL7 Engine UROSTYM Biofeedback And Stimulation Device and Accessories Urocap IV Urocap NXT Urocap V Urocap III Urocap IV Light Goby NXT Aquarius

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2021-07-23
KPI Stimulator, Electrical, Non-Implantable, For Incontinence Gastroenterology, Urology Class 2 876.5320 2021-07-29
HIR Perineometer Obstetrics/Gynecology Class 2 884.1425 2021-07-29
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-05-08
KPI Stimulator, Electrical, Non-Implantable, For Incontinence Gastroenterology, Urology Class 2 876.5320 2021-07-29
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2023-08-08
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2024-05-10
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2024-03-08
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2024-03-08
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2023-08-08
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2024-03-08
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2021-07-23
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2024-03-08
JXE Device, Nerve Conduction Velocity Measurement Neurology Class 2 882.1550 2024-03-08
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2024-03-08
OUG Medical Device Data System General Hospital Class 1 880.6310 2021-08-03
KPI Stimulator, Electrical, Non-Implantable, For Incontinence Gastroenterology, Urology Class 2 876.5320 2021-07-29
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2021-07-23
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2021-02-12

Official Correspondent

Nicole Boser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Laborie Medical Technologies Corp.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880088 Cadwell Laboratories, Inc. CADWELL EXCEL 1988-05-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017448360. Last updated year: 2026. Please use registration number 3017448360 when referencing this establishment in official correspondence.
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