CONTRA HEALTHCARE SOLUTIONS LLC

FDA Device Registration & Listing · Butler, PA, US · Registration 3023809956

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
3023809956
FEI Number
3023809956
Entity Name
CONTRA HEALTHCARE SOLUTIONS LLC
City/State/Country
Butler, PA, US
Establishment Address
105 Lincoln Ave, Butler, PA 16001, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Contra Healthcare Solutions LLC (Owner Number: 10091947)
Owner / Operator Contact Address
9038 Audubon Drive, Gibsonia, PA 15044, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243541
PMA Number
N/A

All Registered Proprietary Names

ContraHealth Ureteroscope ContraHealth Bronchoscope

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-05-01
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2025-05-02

Official Correspondent

Juanita John

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Contra Healthcare Solutions LLC
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
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17
K240075 FUJIFILM Healthcare Americas Corporation FUJIFILM Endoscope Model EB-710XT 2024-02-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2020 AURIS HEALTH INC 2
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023809956. Last updated year: 2026. Please use registration number 3023809956 when referencing this establishment in official correspondence.
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