FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILTEK IRRIGAITON/ASPIRATION TUBE SET
K Number: K922989
·
Decision Feb 15, 1994
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
23
Applicant Total
21
Review Days
603
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
- WILTEK IRRIGAITON/ASPIRATION TUBE SET
- K Number
- K922989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wiltek Medical, Inc.
- Date Received
- June 22, 1992
- Decision Date
- February 15, 1994
- Product Code
- BYY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYY), ordered by most recent decision date.
VITAFLOW SUCTION/ASPIRATION TUBING SET
FDA 510(k)
FDA Class 2
·General Hospital
CONNECTING TUBING
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW
FDA 510(k)
FDA Class 2
·General Hospital
GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Wiltek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990231 | WILTEK HOT BIOPSY FORCEPS | Apr 13, 1999 | Substantially Equivalent |
| K930419 | WILTEK BIOPSY FORCEPS | Jun 1, 1993 | Substantially Equivalent |
| K914882 | WILTEK BALLOON CHOLANGIOGRAPHY CATHETER | Jan 7, 1992 | Substantially Equivalent |
| K914881 | WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Jan 7, 1992 | Substantially Equivalent |
| K914132 | WILTEK ELECTROCAUTERY ACTIVE CORD | Sep 25, 1991 | Substantially Equivalent |
| K914131 | WILTEK ELECTROCAUTERY ADAPTOR | Sep 25, 1991 | Substantially Equivalent |
| K912122 | CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K912288 | WILTEK STANDARD CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K910334 | ELECTROCAUTERY PROBE | Feb 21, 1991 | Substantially Equivalent |
| K894866 | WILTEK STONE EXTRACTOR | Dec 21, 1989 | Substantially Equivalent |