Tubing And Tubing/Filter Fits

NVT · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.1700

Classification

FDA Product Code: NVT
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 884.1700
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 19

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown