Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010966701

FEI Number

3010966701

Entity Name

CUSTOM TUBE MANUFACTURING LLC

City/State/Country

Yangju-si Gyeonggi, KR

Establishment Address

38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon, Yangju-si Gyeonggi 11413, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CUSTOM TUBE MANUFACTURING LLC (Owner Number: 10046953)

Owner / Operator Contact Address

38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon, Yangju-si, KR-41 11413, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPECTRA MSK Ultrasonic Injection Needle SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle SPINAL NEEDLE Vascular Access Port Infusion Set HUBER NEEDLE Disposable Scalpel, One-Piece, Non-Sterile Spectra Soft Tissue Biopsy Needles SPECTRA GUIDE GLIDE II GUIDE WIRE INTRODUCER NEEDLE GUIDE WIRE INTRODUCER NEEDLE SPECTRA GUIDE GLIDE GUIDE WIRE INTRODUCER NEEDLE Epidural Needle for Arrow Anesthesia Conduction Kit Disposable Epidural Anesthesia Tray NEEDLE, ASPIRATION AND INJECTION BSC Insertion Needle (Component - bulk, nonsterile) PENCIL POINT NEEDLE SPECTRA SAFE-CUT SAFETY SCALPEL Introducer Needle SPECTRA Sonic Block Quincke Needle SPECTRA Sonic Block Crawford Needle SPECTRA Sonic Block Chiba Needle SPECTRA Sonic Block Tuohy Needle MANUAL INSTRUMENT RADIOFREQUENCY NEEDLE RF NEEDLE TRUGUIDE COAXIAL BIOPSY NEEDLE BLUNT TIP STYLET FOR TRUGUIDE NEEDLE

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	2016-02-06
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2014-06-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-10-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-06-04
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2014-10-07
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-01-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-06-04
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-04-23
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2014-10-07
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-04-01
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2021-11-17
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2014-06-04
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-06-04
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-06-04
FHR	Needle, Gastro-Urology	General, Plastic Surgery	Class 1	878.4800	2020-12-21
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2017-12-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2014-06-04
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2014-06-04
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2014-06-04
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Kathy Dassler Business: SPECTRA MEDICAL DEVICES, LLC Email: kdassler@spectramedical.com Phone: (978) 6570889

Related Public Records

Same Entity

CUSTOM TUBE MANUFACTURING 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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); 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.

Similar Registrations

Registration Number	Establishment Name	Location
1061124	Sterigenics U.S., LLC	Charlotte, NC, US
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US
1643059	Epimed International, Inc.	Dallas, TX, US
3006561161	Hoogland Spine Products GmbH	Unterfoehring Munich Bavaria, DE
3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010966701. Last updated year: 2026. Please use registration number 3010966701 when referencing this establishment in official correspondence.