Exac-Temp & Clini-Temp Foley Catheter's
FDA 510(k) K925790 · Deroyal Industries, Inc.
510(k) numberK925790
Submission
- Device name
- Exac-Temp & Clini-Temp Foley Catheter's
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- November 16, 1992
- Decision date
- May 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K041416 | Exac-Temp Foley Catheter and Clini-Temp Foley CatheterEYC · Abbreviated | Deroyal | 07/02/2004SE |
| K890310 | Sterile Foley CatheterEYC · Traditional | Kosan Far East Ent. , Ltd. | 11/30/1989SE |
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| K200631 | DeRoyal Temperature Monitoring ProbeFLL · Traditional | 12/23/2020SE |
| K200757 | Foley Catheter with Temperature SensorEYC · Traditional | 10/15/2020SE |
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| K171475 | DeRoyal Laprador Specimen Retrieval SystemGCJ · Traditional | 08/17/2017SE |
| K152978 | DeRoyal Angiography KitsDXT · Traditional | 03/25/2016SESK |
Questions and answers
When was Exac-Temp & Clini-Temp Foley Catheter's cleared by the FDA?
Exac-Temp & Clini-Temp Foley Catheter's (K925790) received a 510(k) decision of Substantially Equivalent on May 17, 1993, 182 days after the submission was received.
What is the product code of K925790?
The FDA product code is EYC – Catheter, Upper Urinary Tract, a Class II (moderate risk) device regulated under 21 CFR 876.5130.