Orion's Urethral Catheterization Kit with Catheter and Bag
FDA 510(k) K944378 · Regulatory & Marketing Services, Inc.
510(k) numberK944378
Submission
- Device name
- Orion's Urethral Catheterization Kit with Catheter and Bag
- Applicant
- Regulatory & Marketing Services, Inc.
Palm Harbor, FL, US - Received
- September 7, 1994
- Decision date
- February 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FGM – Probe And Director, Gastro-Urology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041732 | Cavermap Surgical AidFGM · Traditional | Blue Torch Medical Technologies | 09/21/2004SE |
| K031527 | Modification to Cavermap Surgical AidFGM · Special | Blue Torch Medical Technologies | 06/05/2003SE |
| K010098 | Modification to Cavermap Surgical AidFGM · Special | Uromed Corp. | 02/01/2001SE |
| K993436 | Cavermap Surgical AidFGM · Traditional | Uromed Corp. | 02/11/2000SE |
| K944384 | Orion's Urethral Catheterization Kit Without BagFGM · Traditional | Regulatory & Marketing Services, Inc. | 02/15/1995SE |
| K944379 | Orion's Foley Catheterization Kit with Catheter and BagFGM · Traditional | Regulatory & Marketing Services, Inc. | 02/15/1995SE |
More from Regulatory & Marketing Services, 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 |
| 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 |
| K944377 | Orion's Urinary Drainage SetKNX · Traditional | 12/06/1994SE |
Questions and answers
When was Orion's Urethral Catheterization Kit with Catheter and Bag cleared by the FDA?
Orion's Urethral Catheterization Kit with Catheter and Bag (K944378) received a 510(k) decision of Substantially Equivalent on February 15, 1995, 161 days after the submission was received.
What is the product code of K944378?
The FDA product code is FGM – Probe And Director, Gastro-Urology, a Class I (low risk) device regulated under 21 CFR 876.4730.