SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T— 510(k) K122531
Substantially EquivalentCovidien
FDA 510(k) clearance K122531 for SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T, Substantially Equivalent on 2012-10-09. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code JOH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boulder, CO, US
Recent devices under product code JOH
view all- K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula +4 more
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- K203362 — TRACOE vario
- K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
- K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
More clearances from Covidien
view all- K241486 — Sofsilk Coated Braided Silk Suture
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- K231934 — GIA Stapler with Tri-Staple Technology
- K231240 — MaxTack Motorized Fixation Device
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
Adverse events under product code JOH
product code JOH- Death
- 42
- Injury
- 1,344
- Malfunction
- 5,608
- Other
- 1
- Total
- 6,995
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 K122531
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122531.
Data sourced from openFDA. This site is unofficial and independent of the FDA.