MADgic Laryngo-Tracheal Mucosal Atomization Device— 510(k) K153470
Substantially EquivalentTeleflex Medical
FDA 510(k) clearance K153470 for MADgic Laryngo-Tracheal Mucosal Atomization Device, Substantially Equivalent on 2016-08-19. Applicant: Teleflex Medical. Device class: 2.
Clearance details
- Applicant
- Teleflex Medical
- Product code
- Code CCT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5170
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Recent devices under product code CCT
view allMore clearances from Teleflex Medical
view allAdverse events under product code CCT
product code CCT- Other
- 1
- Total
- 1
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 →
Recalls naming K153470
K-number listed on FDA's recall record- Z-3212-2017 — LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region
- Z-0383-2017 — FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
- Z-0384-2017 — LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153470.
Data sourced from openFDA. This site is unofficial and independent of the FDA.