Last synced on 25 November 2022 at 11:04 pm

Neurosurgical Paddie

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4700
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4700 Neurosurgical paddie

§ 882.4700 Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

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

[44 FR 51730, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004]

Neurosurgical Paddie

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4700
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4700 Neurosurgical paddie

§ 882.4700 Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

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

[44 FR 51730, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004]