Cooper Surgical Inc

FDA Filings

This page includes the latest FDA filings for Cooper Surgical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Cooper Surgical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

ORIGIO A/S

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K143650 Cooper Surgical Inc.	CooperSurgical Advincula Delineator Uterine Manipulator	2015-07-21
PMN K141523 COOPER SURGICAL, INC.	ALLY UPS	2014-11-25
PMN K140754 COOPER SURGICAL, INC.	COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM	2014-10-23

Similar & Related FDA Registered Companies

Coopersurgical, Inc
CooperSurgical, Inc.95 Corporate Drivetrumbull, CT 06611 PMA NumberP160047 Supplement NumberS028 Date Received12/21/2022 Decision Date01/19/2023 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperSurgical, Inc.95 Corporate Drivetrumbull, CT 06611 PMA NumberP160047 Supplement NumberS027 Date Received11/14/2022 Decision Date12/12/2022 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009106539	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	OTHER BRUSH BRUSH	8 PKG
2020090314347	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	OTHER BRUSH BRUSH	8 PKG
202008174315	Stadersand,Federal Republic of Germany -> New York, New York	LABORATORY EQUIPMENT FOR ARTIFICIAL INSEMINAT ION HS 84199085 00	9 PCS
2020080618278	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	LABORATORY EQUIPMENT FOR ARTIFICIAL INSEMINAT ION HS 84199085 00	9 PCS
202008016382	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	OTHER BRUSH BRUSH	180 PKG
2020073019136	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PAPER BOX	137 CTN
2020072219807	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	OTHER BRUSH BRUSH	180 PKG
2020071510844	Stadersand,Federal Republic of Germany -> New York, New York	LABORATORY EQUIPMENT FOR ARTIFICIAL INSEMINAT ION HS 84199085 00	5 PCS