← FDA Medical Device Classifications

Seal, Cervical, Mechanical, Unpowered

QHZ · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.1690

Classification

FDA Product Code
QHZ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 884.1690
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Reduce fluid leakage from the cervix during hysteroscopic procedures.

Market data

Cleared 510(k) submissions
0
Registered establishments
4

Source

Authoritative
FDA Device Classification database
Machine
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