Last synced on 25 November 2022 at 11:04 pm

Rongeur, Powered

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4845
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4845 Powered rongeur

§ 882.4845 Powered rongeur.

(a) Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.

(b) Classification. Class II (performance standards).

Rongeur, Powered

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4845
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4845 Powered rongeur

§ 882.4845 Powered rongeur.

(a) Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.

(b) Classification. Class II (performance standards).