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Riza Band Stretcher (RBS)-60000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001236

by R-Med, Inc.

Identifiers

510(k) Number
K001236 FDA 510(k)
FDA Product Code
FHN 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 Riza Band Stretcher (RBS)-60000 is a hemorrhoidal ligator. It is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

This device is classified as a Class II medical device under regulation number 876.4400. It received FDA 510(k) clearance on July 17, 2000, under submission number K001236.

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: RIZA BAND STRETCHER (RBS)-60000 by R-MED, INC. | FDA 510 (k) Summary, RIZA BAND STRETCHER (RBS)-60000 (K001236) — FDA 510 (k) | Innolitics, RIZA BAND STRETCHER (RBS)-60000 510 (k) K001236 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
R-Med, Inc.

Sources (1)

  • FDA 510(k) K001236 24 fields · synced Oct 6, 2026