FOLEY CATHETERS WITH TEMPERATURE PROBE
FDA 510(k) clearance K061918 · decided 2006-08-18
Clearance details
- K-number
- K061918
- Device name
- FOLEY CATHETERS WITH TEMPERATURE PROBE
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2006-07-06
- Decision date
- 2006-08-18
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- EYC
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Needham, MA, 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 Catheter with Temperature Sensor (K200757) | Deroyal Industries, Inc. | 2020-10-15 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |