FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
K Number: K760253
·
Decision Aug 23, 1976
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
70
Applicant Total
566
Review Days
35
Basic Information
- Device Name
- TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
- K Number
- K760253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- C.R. BARD, INC.
- Date Received
- July 19, 1976
- Decision Date
- August 23, 1976
- Product Code
- GBM
- 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 |
|---|---|---|---|
| GBM | Catheter, Urethral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBM), ordered by most recent decision date.
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Intermittent Catheter (Not Finalized)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SpeediCath Compact Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SpeediCath Compact Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SpeediCath Soft
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by C.R. BARD, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K163001 | PowerFlow Apheresis I.V. Port | Apr 17, 2017 | Substantially Equivalent |
| K162769 | Pinpoint GT Introducer Needle | Nov 4, 2016 | Substantially Equivalent |
| K162443 | PowerPICC Provena Catheters | Oct 25, 2016 | Substantially Equivalent |
| K162377 | PowerGlide Pro Midline Catheter | Sep 22, 2016 | Substantially Equivalent |
| K153280 | PowerGlide Pro Midline Catheter | Jun 2, 2016 | Substantially Equivalent |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | May 20, 2016 | Substantially Equivalent |
| K153236 | Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay | May 13, 2016 | Substantially Equivalent |
| K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit | Apr 29, 2016 | Substantially Equivalent |
| K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | Jun 1, 2015 | Unknown |
| K150345 | Magic3 Go Intermittent Urinary Catheter | May 11, 2015 | Substantially Equivalent |