FDA 510(k) Premarket Notification K963031: GENXCATHETER

Submission Details & Decision

Normalized public record details for 510(k) notification K963031.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K963031

Applicant / Sponsor

Genx Intl., Inc.

Device Name

GENXCATHETER

Product Code

MFD

Decision Date

1996-10-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Obstetrics/Gynecology (OB)

Clearance Type

Traditional

Third Party Flag

Date Received

1996-08-05

Related Establishments / Registrations

COOPERSURGICAL, INC. Registration: 1216677 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Cook Incorporated Registration: 1820334 View Registration
Cook Incorporated Registration: 1825146 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
ALLWIN MEDICAL DEVICES, INC. Registration: 3005987240 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration
COOPER MEDICAL, SRL Registration: 3014295858 View Registration
CooperSurgical Distribution B.V. Registration: 3014755376 View Registration
ROCKET MEDICAL PLC Registration: 9610632 View Registration
Allwin Medical Devices Pvt. Ltd. Registration: 9617744 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.