Product Code: HRT FDA class 1 21 CFR 888.4540

Stripper, Surgical

Orthopedic

A surgical stripper is an orthopedic hand instrument used to strip soft tissue, such as periosteum or tendons, from bone surfaces during surgery. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk subject only to general controls. Product code HRT falls under the Orthopedic medical specialty.

510(k)s
0
FEI Numbers
97
Registration Numbers
97
Unique Applicants
0
Years Active

Research product code HRT in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
HRT
Device Class
FDA class 1
Regulation Number
888.4540
Medical Specialty
Orthopedic
Review Panel
OR
Submission Type
4

Device Characteristics

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

FEI Numbers

This FDA classification entry is associated with 97 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 97 registration numbers. Click on an entry to view related FDA registrations.