Modified Novy Cornual Cannulation Set— 510(k) K180552

Name: FDA 510(k) clearance K180552
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K180552 for Modified Novy Cornual Cannulation Set, Substantially Equivalent on 2018-07-12. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code MOV
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2018-03-01
Decision date: 2018-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOV

view all

K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER1995-11-16
K931476 — NOVY CORNUAL CANNULATION SET1995-07-28
K931534 — OVAMED INTRAUTERINE ACCESS CATHETER1995-07-28
K953314 — CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM1995-07-28

More clearances from Cook Incorporated

view all

K233177 — Nest VT Vitrification Device2024-03-08
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K223098 — Bakri Essential Postpartum Balloon2022-10-28
K210734 — Endovascular Dilator and Sets2021-04-06
K203670 — Extra Large Check-Flo Introducer2021-02-16

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