TUM-E-VAC
FDA 510(k) clearance K962850 · decided 1997-02-21
Clearance details
- K-number
- K962850
- Device name
- TUM-E-VAC
- Applicant
- Ethox Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-22
- Decision date
- 1997-02-21
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- KDH
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ethox Corp.
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 |
|---|---|---|
| GILTECH PLUS CONNECTING TUBE SET (K983624) | Giltech Plus, Inc. | 1999-03-18 |
| SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (K981286) | Armm, Inc. | 1998-06-19 |
| COMBIPORT FLUID LAVAGE DEVICE (K971259) | B.Braun Medical, Inc. | 1997-10-27 |
| EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (K951533) | Ballard Medical Products | 1995-07-05 |
| FLUSHING IRRIGATION SET (K923497) | Orion Life Systems, Inc. | 1994-03-21 |
| TRI-MED GASTRIC LAVAGE SYSTEM (K920619) | Tri-Med Specialties, Inc. | 1992-09-04 |
| TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (K920527) | Tri-Med Specialties, Inc. | 1992-09-04 |
| QUICVAGE PLUS (K914908) | Autovage | 1992-04-13 |
| QUICVAGE (K914907) | Autovage | 1992-01-24 |
| ECONOVAGE R (K911788) | Autovage | 1991-07-26 |
| MINIVAGE(R) (K911919) | Autovage | 1991-07-26 |
| IRRIGATION/ASPIRATION TUBING SET (K911324) | Biomedical Dynamics, Inc. | 1991-06-24 |
Recalls involving this device
No recalls on record reference this clearance.