← Back to catalogue

Bard RapidFire Multiple Band Ligator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971137

by C. R. Bard, Inc.

Identifiers

510(k) Number
K971137 FDA 510(k)
FDA Product Code
MND FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4400 FDA 510(k)
Regulation Number
876.4400 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard RapidFire Multiple Band Ligator is an endoscopic accessory designed for the ligation of esophageal varices and anorectal hemorrhoids. It attaches to an endoscope and utilizes a spool with a crank-trip wire filament to deploy ligating bands.

The device is supplied as a single-use item and is intended for use by trained medical professionals. It is regulated as a Class II medical device under FDA 510(k) clearance (K971137) and is not indicated for MRI safety.

Frequently asked questions

What is the Bard RapidFire Multiple Band Ligator used for?

The Bard RapidFire Multiple Band Ligator is designed for the ligation of esophageal varices and anorectal hemorrhoids during endoscopic procedures, allowing trained medical professionals to deploy ligating bands via a spool and crank-trip wire filament attached to an endoscope.

Is the Bard RapidFire Multiple Band Ligator reusable or single-use?

The device is supplied as a single-use item, meaning it is intended for one procedure only and should be discarded after use to prevent cross-contamination and ensure optimal performance.

How is the Bard RapidFire Multiple Band Ligator supplied and what does it include?

The Bard RapidFire Multiple Band Ligator is supplied as a single-use endoscopic accessory that includes a spool with a crank-trip wire filament mechanism to deploy ligating bands, designed to attach to an endoscope for use in gastrointestinal procedures.

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: BARD RAPIDFIRE MULTIPLE BAND LIGATOR - Innolitics, BARD RAPIDFIRE MULTIPLE BAND LIGATOR (K971137) - FDA 510 (k), BARD RAPIDFIRE MULTIPLE BAND LIGATOR 510(k) K971137 - FDA.report, PDF K971137 - Bard Rapidfire Multiple Band Ligator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K971137 24 fields · synced Sep 26, 2026