Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1224960

FEI Number

3000204727

Entity Name

SPECTRA MEDICAL DEVICES, LLC

City/State/Country

WILMINGTON, MA, US

Establishment Address

299 Ballardvale St Ste 1, WILMINGTON, MA 01887, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SPECTRA MEDICAL DEVICES, LLC (Owner Number: 9012618)

Owner / Operator Contact Address

299 BALLARDVALE STREET, SUITE 1, Wilmington, MA 01887, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPECTRA Sonic Block Chiba Needle SPECTRA Sonic Block Quincke Needle SPECTRA Sonic Block Crawford Needle SPECTRA Sonic Block Tuohy Needle Spectra Epidural Needles Epidural Anesthesia Needle SPECTRA MSK Ultrasonic Injection Needle SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle Sodium Chloride Inj. 0.9% USP 5ml and 10ml Ampule VITREQ Cannula D253552 Cervical Regional Anesthesia Needle Vascular Access Port Infusion Set Spectra Spinal Needles Spinal Needles (various) Glass LOR Syringe Vascular Access Port Huber Point Infusion Needle VITREQ Needle D253554 Instrument,Manual,Surgical, General Spectra Soft Tissue Biopsy Needles SPECTRA Disposable Radio Frequency (RF) Needle NBD Disposable RF Cannula Disposable Epidural Anesthesia Tray Spectra Guidewire Introducer Needle Disposable Scalpel, One-Piece, Non-Sterile Sponge Applicator

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	2017-12-27
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-06-09
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2016-02-06
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2025-12-02
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-09-05
HEE	Set, Anesthesia, Paracervical	Obstetrics/Gynecology	Class 2	884.5100	2009-12-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-06-09
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2008-06-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-12-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-06-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-09-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-05-13
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-01-26
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2008-06-09
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2008-06-09
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-06-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-12-15
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2012-03-10
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-09-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPECTRA MEDICAL DEVICES, 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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1224960. Last updated year: 2026. Please use registration number 1224960 when referencing this establishment in official correspondence.