4-WAY STOPCOCK W/7CM TUBING,
FDA 510(k) clearance K760679 · decided 1976-12-02
Clearance details
- K-number
- K760679
- Device name
- 4-WAY STOPCOCK W/7CM TUBING,
- Applicant
- American Viggo
- Decision
- Substantially Equivalent
- Date received
- 1976-09-20
- Decision date
- 1976-12-02
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- FMG
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American Viggo
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|
| Qitexio® 4-Way Stopcock (QIT014) (K242255) | Medex | 2025-04-29 |
| Three Way Stop Cock (K223499) | M/S Romsons International | 2023-07-21 |
| lntravascular Administration Sets with Stopcock and Manifold (K223175) | Baxter Healthcare Corporation | 2023-03-10 |
| SafePort(TM) Manifold (or Stopcock) (K211204) | Elcam Medical Acal | 2022-09-15 |
| Clicky Cross (K210516) | Yomura Technologies, Inc. | 2022-05-16 |
| TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539) | Monumedical, LLC | 2019-10-22 |
| Elcam Stopcocks and Manifolds (K190489) | Elcam Medical Acal | 2019-04-23 |
| Dynarex Three-Way Stopcock (K172266) | Dynarex Corporation | 2018-03-14 |
| ELCAM STOPCOCKS AND MANIFOLDS (K141254) | Elcam Medical Acal | 2014-07-30 |
| DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD (K123084) | Elcam Medical Acal | 2013-05-23 |
| LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245) | Baxter Healthcare Corp | 2013-03-01 |
| DUAL SYRINGE HOLDER (K082110) | Surgin Surgical Instrumentation, Inc. | 2009-06-17 |
Recalls involving this device
No recalls on record reference this clearance.