FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
QUICVAGE PLUS
K Number: K914908
·
Decision Apr 13, 1992
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
22
Applicant Total
7
Review Days
164
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QUICVAGE PLUS
- K Number
- K914908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Autovage
- Date Received
- November 1, 1991
- Decision Date
- April 13, 1992
- Product Code
- KDH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDH), ordered by most recent decision date.
GILTECH PLUS CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMBIPORT FLUID LAVAGE DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TUM-E-VAC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLUSHING IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Autovage
| K Number | Device Name | ||
|---|---|---|---|
| K922785 | IRRIVAGE | Oct 16, 1992 | Substantially Equivalent |
| K914907 | QUICVAGE | Jan 24, 1992 | Substantially Equivalent |
| K911788 | ECONOVAGE R | Jul 26, 1991 | Substantially Equivalent |
| K911919 | MINIVAGE(R) | Jul 26, 1991 | Substantially Equivalent |
| K840943 | ENDO-JECT | May 25, 1984 | Substantially Equivalent |
| K823195 | GASTRIC LAVAGE KIT | Dec 3, 1982 | Substantially Equivalent |