FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUBING, DYNACOR UNIVERSAL
K Number: K790055
·
Decision Feb 22, 1979
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
238
Review Days
44
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
- TUBING, DYNACOR UNIVERSAL
- K Number
- K790055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medline Industries, Inc.
- Date Received
- January 9, 1979
- Decision Date
- February 22, 1979
- 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 Medline Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210049 | Medline ART Skin Harvesting System | Mar 27, 2024 | Unknown |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Oct 26, 2023 | Substantially Equivalent |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Jun 27, 2023 | Substantially Equivalent |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Jan 25, 2023 | Substantially Equivalent |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Dec 9, 2022 | Substantially Equivalent |
| K212911 | Konig Mogen Clamp | Nov 18, 2022 | Substantially Equivalent |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Oct 25, 2022 | Substantially Equivalent |
| K213481 | Medline General Surgery Tray | May 24, 2022 | Substantially Equivalent |
| K212093 | Medline Universal Grounding Pad | Jan 14, 2022 | Substantially Equivalent |
| K213068 | Medline Smoke Evacuation Shroud | Jan 3, 2022 | Substantially Equivalent |