Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026478941

FEI Number

3026478941

Entity Name

STACLEAR, INC.

City/State/Country

Raleigh, NC, US

Establishment Address

7250 ACC Blvd., Raleigh, NC 27617, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

StaClear, Inc. (Owner Number: 10088128)

Owner / Operator Contact Address

7250 ACC Blvd., Raleigh, NC 27617, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243936

PMA Number

N/A

All Registered Proprietary Names

StaClear StaClear Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLY	Ophthalmic Syringe	General Hospital	Class 2	880.5860	2023-05-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-05-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-01-08
QLY	Ophthalmic Syringe	General Hospital	Class 2	880.5860	2026-01-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-01-08

Official Correspondent

Vinay Sakhrani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

StaClear, Inc.

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
1064858	ANDERSEN SCIENTIFIC, INC.	Morrisville, NC, US
9615588	ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD	WENZHOU Zhejiang, CN
3012552122	SHANGHAI MEKON MEDICAL DEVICES CO., LTD.	shanghai, CN
3005405146	SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.	JIADING Shanghai, CN
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026478941. Last updated year: 2026. Please use registration number 3026478941 when referencing this establishment in official correspondence.