FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
5 - IN - 1 CONNECTOR
K Number: K864964
·
Decision Jan 20, 1987
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
26
Applicant Total
31
Review Days
29
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
- 5 - IN - 1 CONNECTOR
- K Number
- K864964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medovations, Inc.
- Date Received
- December 22, 1986
- Decision Date
- January 20, 1987
- Product Code
- GAZ
- 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 |
|---|---|---|---|
| GAZ | Tubing, Noninvasive | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAZ), ordered by most recent decision date.
SUCTION/IRRIGATOR TUBING KIT
FDA 510(k)
FDA Class 2
·General Hospital
TUBING, NONINVASIVE
FDA 510(k)
FDA Class 2
·General Hospital
SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES
FDA 510(k)
FDA Class 2
·General Hospital
NORTEC CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
FDA 510(k)
FDA Class 2
·General Hospital
MAXI-FLOW SUCTION SET W/Y CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Medovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | Mar 10, 2015 | Substantially Equivalent |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Nov 1, 2000 | Substantially Equivalent |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Feb 2, 1998 | Substantially Equivalent |
| K924646 | OVER THE GUIDEWIRE DILATATION SYSTEM | Dec 5, 1994 | Substantially Equivalent |
| K913678 | TROCAR CATHETER | Dec 16, 1991 | Substantially Equivalent |
| K905478 | YANKAUER SUCTION DEVICE | Dec 19, 1990 | Substantially Equivalent |
| K874309 | URETHAL CATHETER | Dec 7, 1987 | Substantially Equivalent |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | Oct 14, 1987 | Substantially Equivalent |
| K864962 | OBERTO MOUTH PROP | Feb 19, 1987 | Substantially Equivalent |
| K854616 | ENTERAL FEEDING BAG | Jan 23, 1986 | Substantially Equivalent |