FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE SUCTION TUBING SET
K Number: K901761
·
Decision May 7, 1990
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
23
Applicant Total
12
Review Days
19
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Basic Information
- Device Name
- STERILE SUCTION TUBING SET
- K Number
- K901761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Acacia Laboratories, Inc.
- Date Received
- April 18, 1990
- Decision Date
- May 7, 1990
- 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
WILTEK IRRIGAITON/ASPIRATION TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Acacia Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952419 | STERIGAUZE GEL DRESSING | Jul 26, 1995 | Substantially Equivalent |
| K952420 | STERIGAUZE WET DRESSING | Jul 12, 1995 | Substantially Equivalent |
| K951861 | STERICARE WOUND CARE GEL | Jul 11, 1995 | Substantially Equivalent |
| K952414 | PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER | Jun 23, 1995 | Substantially Equivalent |
| K951914 | HYDRACARE ABSORBENT WOUND DRESSING | May 15, 1995 | Substantially Equivalent for Some Indications |
| K950344 | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER | Mar 24, 1995 | Unknown |
| K913408 | STERILE PLASTIC DRAPE | Mar 12, 1992 | Substantially Equivalent |
| K892856 | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | Nov 8, 1989 | Substantially Equivalent |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Jul 14, 1989 | Substantially Equivalent |
| K884055 | SURGI-TAG(TM) STERILE LABEL SETS | Oct 13, 1988 | Substantially Equivalent |