Teleflex Rusch SoftSimplastic Foley Catheters— 510(k) K212077
Substantially EquivalentTeleflexmedical, Inc.
FDA 510(k) clearance K212077 for Teleflex Rusch SoftSimplastic Foley Catheters, Substantially Equivalent on 2023-07-27. Applicant: Teleflexmedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflexmedical, Inc.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Recent devices under product code EZL
view allMore clearances from Teleflexmedical, Inc.
view all- K232469 — Rüsch Latex Gold Foley Catheter
- K192324 — Sheridan Spiral-Flex Endotracheal Tubes
- K182847 — Hudson RCI Voldyne Volumetric Exerciser
- K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
- K183461 — Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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.