Cannula, Injector, Uterine, Endometrial Biopsy

PGK · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.4530

Classification

FDA Product Code: PGK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.4530
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

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