SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle— 510(k) K151069
Substantially EquivalentSpectra Medical Devices, Inc.
FDA 510(k) clearance K151069 for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle, Substantially Equivalent on 2016-02-05. Applicant: Spectra Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectra Medical Devices, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, MA, US
Recent devices under product code BSP
view allMore clearances from Spectra Medical Devices, Inc.
view all- K103740 — SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
- K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
- K082580 — SPECTRA GUIDEWIRE INTRODUCER NEEDLE
- K082674 — SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
- K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.