Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007829657

FEI Number

3007829657

Entity Name

ROBLING MEDICAL, LLC

City/State/Country

Youngsville, NC, US

Establishment Address

90 Weathers Street, Youngsville, NC 27596, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Robling Medical, LLC (Owner Number: 10029999)

Owner / Operator Contact Address

90 Weathers Street, Youngsville, NC 27596, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Intera Special Bolus Needles Intera Refill Needle Intera OR Prep Kit Arisure Neutral Valve Ovesco OTSC System Set Vented Vial Access Device w Smartsite Luminell DTx 360 Rotosheath & Introducer Arisure Dry Closed Male Luer ONO Retrieval Device Intera Refill Kit Irrigator Checkpoint Stimulator Checkpoint Head and Neck Stimulator Pulse Lavage Intera Tapered Silicone Rubber Catheter (Radiopaque) with Connector SonaStar Arisure Closed System Drug Transfer Device (CSTD) CorVista System Checkpoint Guardian Interoperative Lead truFreeze Cryo Ablation System Luminelle Dtx Hysteroscopy System Gadavist Imaging Transfer Spike NuStat Wound Dressing FibuLink Syndesmosis Repair FibuLink Syndesmosis Repair Kit, Titanium

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-03-08
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2025-11-24
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-03-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-11-28
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2016-02-02
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-06-24
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2024-02-27
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-02-27
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2013-03-08
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-12-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-12-20
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-02-22
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-02-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-11-28
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-11-28
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2023-11-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2020-06-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-06-01
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2022-08-15
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2025-11-24
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2013-03-08
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2024-03-07
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-05-11
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-01-04
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-12-30
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-01-04
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2024-03-07
LKK	Pump, Infusion, Implanted, Programmable	Unknown	Class 3	N/A	2025-11-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-10
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-01-10
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2024-03-05
QXX	Coronary Artery Disease Machine Learning-Based Notification Software	Cardiovascular	Class 2	870.2380	2025-01-28
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2014-05-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-02-22
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-03-08
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2023-02-01
POD	Temporary, Internal Use Hemostatic	General, Plastic Surgery	Class 2	878.4454	2020-01-10
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2023-11-28
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-01-10
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2023-02-01
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-01
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2024-03-07
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2017-12-29
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2017-12-29

Official Correspondent

Brent Robling

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Robling Medical, 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
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007829657. Last updated year: 2026. Please use registration number 3007829657 when referencing this establishment in official correspondence.