510(k) K200757
- Device
- Foley Catheter With Temperature Sensor
- Applicant
- DeRoyal Industries, Inc.
- 510(k) number
- K200757
- Product code
- EYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-15
- Date received
- 2020-03-24
- Regulation
- 876.5130
- Classification name
- Catheter, Upper Urinary Tract
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sarah Bennett
- Address
- 200 Debusk Ln. Powell TN US 37849 37849
FDA Registration Numbers#
- 9613793
- 9616088
- 1054241
- 1061124
- 1043214
- 3004111573
- 1055236
- 2320762
- 8030107
- 3010838917
- 1423537
- 3005483737
- 2025851
Source Documents#
Other 510(k) Records For Product Code EYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061918 | FOLEY CATHETERS WITH TEMPERATURE PROBE | GE Healthcare | 2006-08-18 |
| K041416 | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | Deroyal | 2004-07-02 |
| K925790 | EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S | Deroyal Industries, Inc. | 1993-05-17 |
| K890310 | STERILE FOLEY CATHETER | Kosan Far East Ent. , Ltd. | 1989-11-30 |
Legacy Summary#
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FDA Review#
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