Orion Suction Catheter Kit with Sterile Saline
FDA 510(k) K942274 · Regulatory & Marketing Services, Inc.
510(k) numberK942274
Submission
- Device name
- Orion Suction Catheter Kit with Sterile Saline
- Applicant
- Regulatory & Marketing Services, Inc.
Palm Harbor, FL, US - Received
- May 10, 1994
- Decision date
- June 2, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K082725 | Graftguard Pressure Controlling SyringeGBX · Traditional | Maquet Cardiovascular, LLC | 12/17/2008SE |
| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944673 | Mri's All Silicone Foley Catheter Temperature ProbeEZL · Traditional | 04/10/1996SE |
| K954752 | Pediatric Europhylic Foley CatheterEZL · Traditional | 10/30/1995SE |
| K941342 | Pain DocGZB · Traditional | 10/13/1995SE |
| K941543 | Dial Medical KitKOC · Traditional | 02/16/1995SESK |
| K944384 | Orion's Urethral Catheterization Kit Without BagFGM · Traditional | 02/15/1995SE |
| K944379 | Orion's Foley Catheterization Kit with Catheter and BagFGM · Traditional | 02/15/1995SE |
| K944378 | Orion's Urethral Catheterization Kit with Catheter and BagFGM · Traditional | 02/15/1995SE |
| K945874 | Euromedical Poly Tracheotomy TubeJOH · Traditional | 12/27/1994SE |
| K944383 | Orion Red Urethral CatheterEZD · Traditional | 12/06/1994SE |
| K944382 | Orion All Silicone Foley CatheterEZL · Traditional | 12/06/1994SE |
Questions and answers
When was Orion Suction Catheter Kit with Sterile Saline cleared by the FDA?
Orion Suction Catheter Kit with Sterile Saline (K942274) received a 510(k) decision of Unknown on June 2, 1994, 23 days after the submission was received.
What is the product code of K942274?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.