Foley Catheter with Temperature Sensor
FDA 510(k) clearance K200757 · decided 2020-10-15
Clearance details
- K-number
- K200757
- Device name
- Foley Catheter with Temperature Sensor
- Applicant
- Deroyal Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-24
- Decision date
- 2020-10-15
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- EYC
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Powell, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FOLEY CATHETERS WITH TEMPERATURE PROBE (K061918) | GE Healthcare | 2006-08-18 |
| EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (K041416) | Deroyal | 2004-07-02 |
| EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S (K925790) | Deroyal Industries, Inc. | 1993-05-17 |
| STERILE FOLEY CATHETER (K890310) | Kosan Far East Ent. , Ltd. | 1989-11-30 |
Recalls involving this device
No recalls on record reference this clearance.