Robling Medical, LLC
Youngsville, NC, US
ROBLING MEDICAL, LLC appears in FDA device records in Youngsville, NC. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Robling Medical, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Apogee Medical, Inc.510(k), recall
510(k) clearance history
FDA records hold 4 510(k) clearances for Robling Medical, LLC between 2001 and 2016. The busiest year on record is 2016, with 2. The most recent is 2016, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2004 | 1 |
| 2016 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160795 | United Urologics Intermittent Catheter | GBM | Substantially Equivalent | |
| K160877 | United Urologics Closed System Catheter | KOD | Substantially Equivalent | |
| K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | KOD | Substantially Equivalent | |
| K011552 | UROLOGICAL CATHETER | GBM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007829657 | 3007829657 | ROBLING MEDICAL, LLC | 90 Weathers Street, Youngsville, NC 27596 US | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- GCEAdaptor, Catheter
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- GBMCatheter, Urethral
- KODCatheter, Urological
- FZPClip, Implantable
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- QXXCoronary Artery Disease Machine Learning-Based Notification Software
- FAJCystoscope And Accessories, Flexible/Rigid
- MMXDevice, Percutaneous Retrieval
- KKXDrape, Surgical, Antimicrobial
- OOLElectronic Depth Gauge
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- LROGeneral Surgery Tray
- PKLHemostatic Metal Clip For The Gi Tract
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- HIHHysteroscope (And Accessories)
- LFLInstrument, Ultrasonic Surgical
- PQHIodinated Contrast Media Transfer Tubing Set
- FQHLavage, Jet
- FMINeedle, Hypodermic, Single Lumen
- PTINon-Coring (Huber) Needle
- LKKPump, Infusion, Implanted, Programmable
- DTNReservoir, Blood, Cardiopulmonary Bypass
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- ETNStimulator, Nerve
- BSRStylet, Tracheal Tube
- QPBSystem, Suction, Lipoplasty For Removal
- PODTemporary, Internal Use Hemostatic
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- GEHUnit, Cryosurgical, Accessories
- EXSUrinometer, Electrical
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2133-2011 | Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations | Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica. | Terminated | ||
| Z-1040-2011 | Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. | Terminated | ||
| Z-1039-2011 | Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. | Terminated | ||
| Z-1038-2011 | Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. | Terminated | ||
| Z-1037-2011 | Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. | Terminated | ||
| Z-1036-2011 | Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. | Terminated | ||
| Z-1035-2011 | Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. | Terminated | ||
| Z-1034-2011 | Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. | Terminated | ||
| Z-2394-2008 | Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | Terminated | ||
| Z-2393-2008 | Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | Terminated | ||
| Z-2392-2008 | Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | Terminated | ||
| Z-2391-2008 | Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | Terminated | ||
| Z-2390-2008 | Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain