Product Code: FXR FDA class 1 21 CFR 878.4160

Holder, Camera, Surgical

General, Plastic Surgery

A surgical camera holder is a mechanical mounting or holding device used to support and position a surgical camera in the operating room, providing a stable platform for image capture. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXR, regulated under 21 CFR 878.4160, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

510(k)s
2
FEI Numbers
24
Registration Numbers
24
Unique Applicants
2
Years Active
4

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Basic Information

Product Code
FXR
Device Class
FDA class 1
Regulation Number
878.4160
Medical Specialty
General, Plastic Surgery
Review Panel
SU
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 2 510(k) clearances via K numbers.

K Number Device Name
K850122 SONI-LOK SCOPE STABILIZER
K810303 TELEVISION CAMERA HOLDER FOR SURGERY

FEI Numbers

This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.