Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008772421

FEI Number

3008772421

Entity Name

ADAPTA MEDICAL, INC.

City/State/Country

Colorado Springs, CO, US

Establishment Address

142 Talamine Ct, Colorado Springs, CO 80907, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Adapta Medical, Inc (Owner Number: 10033957)

Owner / Operator Contact Address

142 Talamine Court, Colorado Springs, CO 80907, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161445

PMA Number

N/A

All Registered Proprietary Names

mPower Cath Hydro-S PerfIC Cath Hydro-C mPower Cath Hydro-C PerfIC Cath Hydro-S PerfIC Cath Gel-S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2017-01-03

Official Correspondent

Glen House

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Adapta Medical, Inc

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008772421. Last updated year: 2026. Please use registration number 3008772421 when referencing this establishment in official correspondence.