Acmi Disposable Bipolar Cord, Model Dbc
510(k) K022480
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022480 | Date22 Aug 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Acmi Corporation
Questions
AI-generated answers, 21 Sep 2026
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).