DEKA TAC DEVICE
FDA 510(k) clearance K093915 · decided 2011-08-23
Clearance details
- K-number
- K093915
- Device name
- DEKA TAC DEVICE
- Applicant
- Deka Research & Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-22
- Decision date
- 2011-08-23
- Days to decision
- 609 days
- Clearance type
- Traditional
- Product code
- FIG
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Manchester, NH, 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 |
|---|---|---|
| ELS AUTOMATIC TUBING CLAMP SYSTEM (K921993) | Rocky Mountain Research, Inc. | 1994-01-05 |
| AUTOMATIC TUBING CLAMP (K914459) | Rocky Mountain Research, Inc. | 1992-06-24 |
| C-DAK 3500 (K770535) | Cordis Corp. | 1977-04-15 |
Recalls involving this device
No recalls on record reference this clearance.