Spectra Medical Devices, LLC
Wilmington, MA, US
SPECTRA MEDICAL DEVICES, LLC appears in FDA device records in Wilmington, MA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Spectra Medical Devices, LLC between 2008 and 2017. The busiest year on record is 2008, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 3 |
| 2009 | 1 |
| 2011 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford | BSP | Substantially Equivalent | |
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle | BSP | Substantially Equivalent | |
| K142791 | Spectra Soft Tissue Biopsy Needles | KNW | Substantially Equivalent | |
| K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | NGT | Substantially Equivalent | |
| K082689 | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE | NGT | Substantially Equivalent | |
| K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | DYB | Substantially Equivalent | |
| K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE | FMF | Substantially Equivalent | |
| K081524 | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1224960 | 3000204727 | SPECTRA MEDICAL DEVICES, LLC | 299 Ballardvale St Ste 1, WILMINGTON, MA 01887 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAZAnesthesia Conduction Kit
- KXFApplicator, Absorbent Tipped, Non-Sterile
- GESBlade, Scalpel
- HMXCannula, Ophthalmic
- GXDGenerator, Lesion, Radiofrequency
- GDFGuide, Needle, Surgical
- GDZHandle, Scalpel
- KNWInstrument, Biopsy
- MDMInstrument, Manual, Surgical, General Use
- DYBIntroducer, Catheter
- GAANeedle, Aspiration And Injection, Disposable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FHRNeedle, Gastro-Urology
- FMINeedle, Hypodermic, Single Lumen
- MIANeedle, Spinal, Short Term
- GXIProbe, Radiofrequency Lesion
- NGTSaline, Vascular Access Flush
- GDXScalpel, One-Piece
- FPASet, Administration, Intravascular
- HEESet, Anesthesia, Paracervical
- FMFSyringe, Piston
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2873-2026 | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices. | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure. | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain