Last synced on 24 June 2022 at 11:05 pm

Needle, Spinal, Short Term, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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, Spinal, Short Term, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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).