Lamicel Osmotic Cervical Dilator

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P820075510(k) K122391

by Medtronic Xomed, Inc.

Identity

Trade Name: LAMICEL(TM) FDA PMA
Generic Name: dilator, cervical, synthetic, osmotic, pregnancy termination FDA PMA

Identifiers

PMA Number: P820075 FDA PMA
510(k) Number: K122391 FDA PMA
FDA Product Code: LOB FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Obstetrics/Gynecology FDA PMA
FDA Decision: APPR Approved FDA PMA
PMA Supplement: S002 FDA PMA

The Lamicel Osmotic Cervical Dilator is a synthetic, osmotic device designed for cervical dilation. It is specifically indicated for use in pregnancy termination procedures to facilitate the necessary clinical access.

This device is manufactured by Medtronic Xomed, Inc. It is regulated under the product code LOB and is associated with FDA 510K and PMA authorizations. Please consult the product labeling for specific usage guidelines and safety information.

Frequently asked questions

What is the primary function of the Lamicel Osmotic Cervical Dilator?

The Lamicel Osmotic Cervical Dilator is a synthetic device used to achieve cervical dilation, which is required during pregnancy termination procedures.

Who is the manufacturer of this device?

The Lamicel Osmotic Cervical Dilator is manufactured by Medtronic Xomed, Inc., located in Jacksonville, Florida.

How is this device regulated?

The device is regulated under product code LOB and holds both FDA 510K and PMA authorizations, confirming its status as a medical device for obstetric and gynecological use.

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. Sources consulted: Premarket Approval (PMA) - FDA, LAMICEL OSMOTIC CERVICAL DILATOR Trademark | Trademarkia, LAMICEL OSMOTIC CERVICAL DILATOR PMA P820075S008 ..., Other mechanical methods for pre-induction cervical ripening, Premarket Approval (PMA) - FDA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K122391	Class III	Active
FDA PMA	United States	FDA_PMA	P820075	Class III	Active

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (2)

FDA PMA P820075 37 fields · synced Sep 18, 2026
FDA 510(k) K122391 1 fields · synced May 18, 2026