Primary Care Solutions Sterile Water Device Irrigation
FDA 510(k) K000265 · Primary Care Solutions, Inc.
510(k) numberK000265
Submission
- Device name
- Primary Care Solutions Sterile Water Device Irrigation
- Applicant
- Primary Care Solutions, Inc.
Ringwood, NJ, US - Received
- January 28, 2000
- Decision date
- July 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOL – Catheter And Tip, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code JOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051370 | Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014JOL · Traditional | Baxter Healthcare Corp | 08/12/2005SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | Welcon, Inc. | 05/01/2001SE |
| K994321 | Sterile Water and 0.9% Sodium Chloride for Irrigation, UspJOL · Traditional | Automatic Liquid Packaging, Inc. | 10/25/2000SE |
| K974759 | Hydrox Saline Solution 0.9% Sodium Chloride 4 Oz. Cup 120 ML 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974758 | Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974397 | Sterile Saline for Catheter CareJOL · Traditional | Baxter Healthcare Corp | 02/10/1998SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | Welcon, Inc. | 02/05/1998SE |
| K972372 | Germ Trapper Suction Tube HolderJOL · Traditional | Rzv Medical Specialties, Inc. | 12/11/1997SE |
| K960216 | CPR Suction Catheter KitJOL · Traditional | Custom Pack Reliability | 04/15/1996SE |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K082330 | Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationFRO · Traditional | 10/09/2008SE |
| K030813 | Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile…EZL · Traditional | 05/30/2003SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | 07/12/2001SE |
Questions and answers
When was Primary Care Solutions Sterile Water Device Irrigation cleared by the FDA?
Primary Care Solutions Sterile Water Device Irrigation (K000265) received a 510(k) decision of Substantially Equivalent on July 12, 2001, 531 days after the submission was received.
What is the product code of K000265?
The FDA product code is JOL – Catheter And Tip, Suction, a Class II (moderate risk) device regulated under 21 CFR 880.6740.