Product Code: HBR FDA class 1 21 CFR 882.4215

Rack, Clip

Neurology

The Clip Rack is a storage and organization accessory used in neurosurgical procedures to hold and present multiple clips of various sizes in a sterile and accessible manner for the surgeon or surgical team during clip application procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HBR under regulation 21 CFR 882.4215 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

510(k)s
1
FEI Numbers
16
Registration Numbers
16
Unique Applicants
1
Years Active

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Basic Information

Product Code
HBR
Device Class
FDA class 1
Regulation Number
882.4215
Medical Specialty
Neurology
Review Panel
NE
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 1 510(k) clearance via K numbers.

K Number Device Name
K890231 SURGICAL TOWEL CLIPS

FEI Numbers

This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.