FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Teleflex Rusch SoftSimplastic Foley Catheters
K Number: K212077
·
Decision Jul 27, 2023
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
64
Review Days
755
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Basic Information
- Device Name
- Teleflex Rusch SoftSimplastic Foley Catheters
- K Number
- K212077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleflexmedical, Inc.
- Date Received
- July 2, 2021
- Decision Date
- July 27, 2023
- Product Code
- EZL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZL), ordered by most recent decision date.
Rusch SoftSimplastic Foley Catheters
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InnoCare Specialty Foley Catheter
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Rüsch Latex Gold Foley Catheter
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TraumaGuard Intra-abdominal Pressure Sensing System
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FDA Class 2
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Folysil Silicone Catheter
FDA 510(k)
FDA Class 2
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Other Clearances by Teleflexmedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232469 | Rüsch Latex Gold Foley Catheter | Aug 1, 2024 | Substantially Equivalent |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Dec 6, 2019 | Substantially Equivalent |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Jul 1, 2019 | Substantially Equivalent |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | May 24, 2019 | Substantially Equivalent |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | May 8, 2019 | Unknown |
| K181852 | Percuvance Percutaneous Surgical System | Oct 12, 2018 | Substantially Equivalent |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Aug 2, 2018 | Substantially Equivalent |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Feb 12, 2018 | Substantially Equivalent |
| K161770 | Rusch Silicone Foley Catheter | May 5, 2017 | Substantially Equivalent |
| K162522 | UltraCath Continuous Nerve block Catheter | Mar 17, 2017 | Substantially Equivalent |