Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012422952

FEI Number

3012422952

Entity Name

INTUIT MEDICAL PRODUCTS, LLC

City/State/Country

Lawrenceville, GA, US

Establishment Address

1990 Riverside Parkway, Lawrenceville, GA 30043, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Intuit Medical Products, LLC (Owner Number: 10050055)

Owner / Operator Contact Address

1990 Riverside Parkway, Lawrenceville, GA 30043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153484

PMA Number

N/A

All Registered Proprietary Names

ClearPath Nasal Balloon System ClearPath Nasal Balloon Guide Spatula ClearPath Nasal Balloon System ClearPath Nasal Balloon Guide Spatula Dillard Airway Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-01-06
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-10-08
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2021-01-06
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2017-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intuit Medical Products, 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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Similar Registrations

Registration Number	Establishment Name	Location
8040881	MEDISPOREX (PVT) LTD.	SIALKOT Punjab, PK
1222274	DESIGN STANDARDS CORP.	CHARLESTOWN, NH, US
9610773	OLYMPUS WINTER & IBE GMBH	HAMBURG, DE
8040172	BURAQ SURGICAL CORP.	SIALKOT Punjab, PK
3009420946	HUANGHUA PROMISEE DENTAL CO., LTD	Huanghua Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012422952. Last updated year: 2026. Please use registration number 3012422952 when referencing this establishment in official correspondence.