CT-STOR
FDA 510(k) clearance K201789 · decided 2021-09-20
Clearance details
- K-number
- K201789
- Device name
- CT-STOR
- Applicant
- Energy Delivery Solutions
- Decision
- Substantially Equivalent
- Date received
- 2020-06-30
- Decision date
- 2021-09-20
- Days to decision
- 447 days
- Clearance type
- Traditional
- Product code
- NDS
- Device class
- 2
- Regulation number
- 876.5885
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jeffersonville, IN, US
- Third-party review
- No
- Expedited review
- No
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| AIM-V (R) MEDIUM, MODEL 087-0112 (K022086) | Invitrogen Corporation | 2002-12-23 |
| DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (DEN000008) | Life Technologies, Inc. | 2001-02-16 |
Recalls involving this device
No recalls on record reference this clearance.