SHILEY FENESTRATED LOW PRESS. CUFFED— 510(k) K812302
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K812302 for SHILEY FENESTRATED LOW PRESS. CUFFED, Substantially Equivalent on 1981-09-08. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, Inc.
- 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
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JOH
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- K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
- 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 Shiley, Inc.
view allAdverse 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 K812302
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 K812302.
Data sourced from openFDA. This site is unofficial and independent of the FDA.