← FDA Medical Device Classifications

Clip, Tubal Occlusion

HGB · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.5380

Classification

FDA Product Code
HGB
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 884.5380
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Definition

Call for PMAs 12/30/87 (52 FR 36883 10/1/87))

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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