AUTOMATIC TUBING CLAMP
FDA 510(k) clearance K914459 · decided 1992-06-24
Clearance details
- K-number
- K914459
- Device name
- AUTOMATIC TUBING CLAMP
- Applicant
- Rocky Mountain Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-07
- Decision date
- 1992-06-24
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- FIG
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rocky Mountain Research
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DEKA TAC DEVICE (K093915) | Deka Research & Development Corp. | 2011-08-23 |
| ELS AUTOMATIC TUBING CLAMP SYSTEM (K921993) | Rocky Mountain Research, Inc. | 1994-01-05 |
| C-DAK 3500 (K770535) | Cordis Corp. | 1977-04-15 |
Recalls involving this device
No recalls on record reference this clearance.