Foley Catheter with Temperature Sensor
FDA 510(k) K200757 · Deroyal Industries, Inc.
510(k) numberK200757
Submission
- Device name
- Foley Catheter with Temperature Sensor
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- March 24, 2020
- Decision date
- October 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K061918 | Foley Catheters with Temperature ProbeEYC · Traditional | GE Healthcare | 08/18/2006SE |
| K041416 | Exac-Temp Foley Catheter and Clini-Temp Foley CatheterEYC · Abbreviated | Deroyal | 07/02/2004SE |
| 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 |
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Questions and answers
When was Foley Catheter with Temperature Sensor cleared by the FDA?
Foley Catheter with Temperature Sensor (K200757) received a 510(k) decision of Substantially Equivalent on October 15, 2020, 205 days after the submission was received.
What is the product code of K200757?
The FDA product code is EYC – Catheter, Upper Urinary Tract, a Class II (moderate risk) device regulated under 21 CFR 876.5130.