Product Code: CAM FDA class 1 21 CFR 868.6885

Yoke Assembly, Medical Gas

Anesthesiology

The Medical Gas Yoke Assembly is a mechanical connector used in anesthesiology to attach a compressed gas cylinder to an anesthesia machine or gas delivery system, providing a secure, standardized interface that ensures proper connection and prevents cross-connection of gas supplies. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CAM, regulated under 21 CFR 868.6885, within the Anesthesiology medical specialty. No special flags apply to this device.

510(k)s
8
FEI Numbers
21
Registration Numbers
21
Unique Applicants
5
Years Active
17

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Basic Information

Product Code
CAM
Device Class
FDA class 1
Regulation Number
868.6885
Medical Specialty
Anesthesiology
Review Panel
AN
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number Device Name
K935283 YOKE ASSEMBLY MEDICAL GAS
K851219 FILL HOSE SAFETY ADAPTER
K851217 PENOX DUAL FLOW MINIFOLD
K851216 PENOX DUAL FEED MANIFOLD
K851215 T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
K840326 GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB
K780365 OXYGEN/NITROUS OXIDE OUTLET
K770426 OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE

FEI Numbers

This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.