Exac-Temp Foley Catheter and Clini-Temp Foley Catheter
FDA 510(k) K041416 · Deroyal
510(k) numberK041416
Submission
- Device name
- Exac-Temp Foley Catheter and Clini-Temp Foley Catheter
- Applicant
- Deroyal
Powell, TN, US - Received
- May 27, 2004
- Decision date
- July 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EYC – Catheter, Upper Urinary Tract
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200757 | Foley Catheter with Temperature SensorEYC · Traditional | Deroyal Industries, Inc. | 10/15/2020SE |
| K061918 | Foley Catheters with Temperature ProbeEYC · Traditional | GE Healthcare | 08/18/2006SE |
| K925790 | Exac-Temp & Clini-Temp Foley Catheter'sEYC · Traditional | Deroyal Industries, Inc. | 05/17/1993SE |
| K890310 | Sterile Foley CatheterEYC · Traditional | Kosan Far East Ent. , Ltd. | 11/30/1989SE |
More from Kosan Far East Ent. , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K033057 | Deroyal Surgical Gowns, Sterile, Non-SterileFYA · Traditional | 11/20/2003SE |
| K031408 | Deroyal Poly-Reinforced Surgical Gowns (Sterile, Non-Sterile)FYA · Traditional | 10/15/2003SE |
| K030908 | Deroyal Surgical Drapes Backtable CoverKKX · Traditional | 08/11/2003SE |
| K020753 | Deroyal Surgical, UmbilicupKSR · Traditional | 06/13/2002SE |
Questions and answers
When was Exac-Temp Foley Catheter and Clini-Temp Foley Catheter cleared by the FDA?
Exac-Temp Foley Catheter and Clini-Temp Foley Catheter (K041416) received a 510(k) decision of Substantially Equivalent on July 2, 2004, 36 days after the submission was received.
What is the product code of K041416?
The FDA product code is EYC – Catheter, Upper Urinary Tract, a Class II (moderate risk) device regulated under 21 CFR 876.5130.