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Acmi Disposable Bipolar Cord, Model Dbc

by Acmi Corporation

510(k) K022480

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK022480 Date22 Aug 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Acmi Disposable Bipolar Cord, Model Dbc is a conductive interface between an electrosurgical unit and a bipolar resectoscope electrode, transmitting RF power for electrosurgery. It consists of a twisted wire pair, shielded cable, distal 'c-spring' contacts with polyurethane over-mold, and proximal two-pin female connector with PVC strain relief.

The device is supplied as a disposable, single-use item and is classified as a Hysteroscope (and Accessories) with a product code of HIH. It has been cleared by the FDA with a 510(k) clearance, specifically K022480, and is intended for use in obstetrics and gynecology. The device is stored and used in a medical setting, with no specific storage conditions stated. It is regulated under the FDA's special controls for Class II devices.

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Questions

AI-generated answers, 21 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 ACMI Disposable Bipolar Cord used for?

    The ACMI Disposable Bipolar Cord is used as a conductive interface between an electrosurgical unit and a bipolar resectoscope electrode, transmitting RF power for electrosurgery in obstetrics and gynecology.

  • Is the ACMI Disposable Bipolar Cord reusable?

    No, the ACMI Disposable Bipolar Cord is supplied as a disposable, single-use item.

  • How is the ACMI Disposable Bipolar Cord stored?

    The device is stored in a medical setting, with no specific storage conditions stated.

  • What is the product code for the ACMI Disposable Bipolar Cord?

    The product code for the ACMI Disposable Bipolar Cord is HIH, classified as a Hysteroscope (and Accessories).