Pre-Filled Syringe W/Sterile .25% Acetc Acid
FDA 510(k) K943835 · Orion Life Systems, Inc.
510(k) numberK943835
Submission
- Device name
- Pre-Filled Syringe W/Sterile .25% Acetc Acid
- Applicant
- Orion Life Systems, Inc.
Palm Harbor, FL, US - Received
- August 5, 1994
- Decision date
- January 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNY – Accessories, Catheter, G-U
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K141252 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 06/09/2014SE |
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| K123170 | Vari-Pass Variable Length Access SheathKNY · Special | Olympus Surgical Technologies America | 02/04/2013SE |
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More from Avail Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943836 | Pre-Filled 10CC Inflation Syringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943834 | Sterile .9% Sodium Chloride SolutionJOL · Traditional | 11/21/1994SE |
| K943832 | Sterile .9% Sodium Chloride for IrrationJOL · Traditional | 11/21/1994SE |
| K943831 | Pre-Filled 30CC Inflation Syringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943830 | Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride SolutionJOL · Traditional | 11/21/1994SE |
| K943829 | Pre-Filled Sysringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943828 | Sterile Water for IrrigationJOL · Traditional | 11/21/1994SE |
| K943833 | Sterile Water for IrrationJOL · Traditional | 11/01/1994SE |
| K923168 | Dual Port Enteral Y-AdaptorKNT · Traditional | 06/17/1994SE |
| K923497 | Flushing Irrigation SetKDH · Traditional | 03/21/1994SESK |
Questions and answers
When was Pre-Filled Syringe W/Sterile .25% Acetc Acid cleared by the FDA?
Pre-Filled Syringe W/Sterile .25% Acetc Acid (K943835) received a 510(k) decision of Substantially Equivalent on January 24, 1995, 172 days after the submission was received.
What is the product code of K943835?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.