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Falope-Ring Band Contraceptive Tubal Occlusion System

FDA PMA

Class III (US FDA PMA)

PMA P870076

by Gyrus Acmi, Inc.

Identity

Trade Name
FALOPE RING BAND AND APPLICATOR SYSTEMS FDA PMA
Generic Name
Laparoscopic contraceptive tubal occlusion device FDA PMA

Identifiers

PMA Number
P870076 FDA PMA
FDA Product Code
KNH FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 884.5380 FDA PMA
Regulation Number
884.5380 FDA PMA
Advisory Committee
Obstetrics/Gynecology FDA PMA
FDA Decision
APPR Approved FDA PMA

The Falope-Ring Band Contraceptive Tubal Occlusion System is a laparoscopic contraceptive tubal occlusion device designed for permanent sterilisation. It consists of a band and applicator system intended to occlude the fallopian tubes, preventing pregnancy through mechanical obstruction.

This device is supplied sterile and intended for single-use in a surgical setting. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA) application. The system is regulated under the product code KNH and is authorised for use in obstetrics/gynecology procedures.

Frequently asked questions

What is the primary purpose of the Falope-Ring Band Contraceptive Tubal Occlusion System and how does it work?

The Falope-Ring Band Contraceptive Tubal Occlusion System is designed for permanent sterilization by mechanically occluding the fallopian tubes during a laparoscopic procedure. It prevents pregnancy by blocking the passage of eggs from the ovaries to the uterus, ensuring contraception through physical obstruction rather than hormonal intervention.

Is the Falope-Ring Band Contraceptive Tubal Occlusion System intended for reuse or single-use, and how is it supplied?

The device is sterile and intended for single-use only in surgical settings. It comes as a complete band and applicator system, ensuring each patient receives a new, uncontaminated unit to maintain safety and efficacy during the procedure.

What regulatory pathway does the Falope-Ring Band Contraceptive Tubal Occlusion System follow, and what classification does it hold?

The Falope-Ring Band Contraceptive Tubal Occlusion System requires Premarket Approval (PMA) under FDA regulations, as it is classified as a Class III medical device. This designation reflects its role in permanent sterilization, necessitating rigorous pre-market review to ensure safety and effectiveness. The device is regulated under product code KNH for obstetrics/gynecology procedures.

Are there different sizes or models available for the Falope-Ring Band Contraceptive Tubal Occlusion System?

The provided data does not specify distinct sizes or models beyond the band and applicator system as a unified unit. However, the system is designed to accommodate standard laparoscopic techniques, and variations (if any) would be determined by the manufacturer’s surgical guidelines or anatomical considerations during placement.

How should the Falope-Ring Band Contraceptive Tubal Occlusion System be stored, and what precautions should be taken?

While the data does not detail storage instructions, as a sterile, single-use device, it should be stored in its original packaging in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Follow the manufacturer’s guidelines to preserve sterility until immediate preoperative use, as re-sterilization is not intended.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA PMA P870076 24 fields · synced Sep 18, 2026