Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010592727

FEI Number

3010592727

Entity Name

SOLO-DEX

City/State/Country

Wolf Creek, MT, US

Establishment Address

1576 MT Highway 434, Wolf Creek, MT 59648, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Solo-Dex (Owner Number: 10052704)

Owner / Operator Contact Address

1576 MT Hwy 434, Wolf Creek, MT 59648, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151072

PMA Number

N/A

All Registered Proprietary Names

Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2016-09-15

Official Correspondent

Albert Rego

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Solo-Dex

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010592727. Last updated year: 2026. Please use registration number 3010592727 when referencing this establishment in official correspondence.