Last synced on 24 June 2022 at 11:05 pm

Needle, Conduction, Anesthetic (W/Wo Introducer)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5150
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5150 Anesthesia conduction needle

§ 868.5150 Anesthesia conduction needle.

(a) Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

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

Needle, Conduction, Anesthetic (W/Wo Introducer)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5150
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5150 Anesthesia conduction needle

§ 868.5150 Anesthesia conduction needle.

(a) Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

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