HET

Laparoscope, Gynecologic (And Accessories)

Product code
HET
Device name
Laparoscope, Gynecologic (And Accessories)
Device class
Class 2
21 CFR
21 CFR 884.1720
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
338 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-08-29.

NumberDecision dateApplicantDevice nameSummary
K2509392025-08-29Precision Robotics (Hong Kong) LimitedSIRIUS Endoscope System (PR-SI-1230)PDF
K2438212025-04-25A.M.I. Agency For Medical Innovations …i-CutPDF

2 summaries are archived here for direct download.

Official FDA classification page: HET
Classification and pathway per current FDA publications. Data from openFDA (CC0).