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Disposable Amniotome

by Galenica Enterprises, Inc.

510(k) K883283

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883283 Date18 Oct 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGG
Device Class
Class II
Regulation
21 CFR Part 884.5070
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A disposable amniotome is a medical device used to rupture the amniotic membrane during obstetric procedures. It is classified as a Class II device under regulation number 884.5070 and is substantially equivalent to a legally marketed predicate device.

The device is supplied sterile and intended for single-use in clinical settings. It received FDA 510(k) clearance (K883283) on October 18, 1988, and is manufactured by Galenica Enterprises, Inc. No information regarding MRI safety, sizes, or storage conditions is provided in the data.

Other devices from Galenica Enterprises, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the disposable amniotome used for?

    The disposable amniotome is used to rupture the amniotic membrane during obstetric procedures, as it is designed specifically for this clinical purpose in managing labor and delivery.

  • Is the disposable amniotome sterile and for single-use only?

    Yes, the device is supplied sterile and intended for single-use in clinical settings, meaning it should be used once and then discarded to prevent cross-contamination and ensure patient safety.

  • Who manufactures the disposable amniotome and when was it cleared?

    The disposable amniotome is manufactured by Galenica Enterprises, Inc. and received FDA 510(k) clearance (K883283) on October 18, 1988, following a traditional review process.