STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING— 510(k) K974028

Name: FDA 510(k) clearance K974028
Creator: U.S. Food and Drug Administration
Published: 1998-01-21

Substantially Equivalent

Conceptus, Inc.

FDA 510(k) clearance K974028 for STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING, Substantially Equivalent on 1998-01-21. Applicant: Conceptus, Inc.. Device class: 2.

Clearance details

Applicant: Conceptus, Inc.
Product code: Code MKO
Device class: Class 2
Regulation: 21 CFR 884.1690
Advisory panel: Obstetrics/Gynecology
Date received: 1997-10-23
Decision date: 1998-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKO

view all

K221965 — FemDx FalloView2023-03-17
K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM1997-01-31
K963580 — IMAGYN FALLOPOSCOPY SYSTEM1997-01-31

More clearances from Conceptus, Inc.

view all

K972210 — RESECTOSCOPE SAFETY SHEATH1997-09-05
K954164 — HYSTEROSCOPE1996-03-12
K953314 — CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM1995-07-28
K932387 — CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL1995-03-06
K932993 — INTRAUTERINE CATHETER AND INTRODUCER1995-01-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.