FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL POOLE SUCTION TUBE
K Number: K896556
·
Decision Feb 6, 1990
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
28
Review Days
81
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
- UNIVERSAL POOLE SUCTION TUBE
- K Number
- K896556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
- Date Received
- November 17, 1989
- Decision Date
- February 6, 1990
- Product Code
- GCX
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCX), ordered by most recent decision date.
STRYKER CASSETTE PUMP
FDA 510(k)
FDA Class 2
·General Hospital
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SUCTION INSTRUMENTATION
FDA 510(k)
FDA Class 2
·General Hospital
CHASE SUCKER
FDA 510(k)
FDA Class 2
·General Hospital
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
FDA 510(k)
FDA Class 2
·General Hospital
CURITY THORACENTESIS TRAY
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Westmark, Sterile Packing Systems, Inc. (Sps)
| K Number | Device Name | ||
|---|---|---|---|
| K896800 | IRRIGATION TRAY | May 24, 1990 | Unknown |
| K896799 | PARACERVICAL/PUDENDAL TRAYS | Apr 23, 1990 | Substantially Equivalent |
| K896559 | INFANT FEEDING TUBE | Mar 13, 1990 | Substantially Equivalent |
| K896794 | SPECIMEN CONTAINER | Mar 1, 1990 | Substantially Equivalent |
| K896806 | CATHETER PLUG/PROTECTOR | Feb 26, 1990 | Substantially Equivalent |
| K896798 | TRACHEOSTOMY TRAY | Feb 22, 1990 | Substantially Equivalent |
| K896797 | SUCTION CATHETER KIT | Feb 16, 1990 | Substantially Equivalent |
| K896215 | MERCY HIP/KNEE PACK | Feb 13, 1990 | Substantially Equivalent |
| K896804 | MANIFOLD | Feb 8, 1990 | Substantially Equivalent |
| K896562 | STOPCOCK | Feb 6, 1990 | Substantially Equivalent |