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RIWOLITH 2135

by R. Wolf Medical Instruments Corp. 510(k)

Active United States

510(k) K822644

Overview

The RIWOLITH 2135 is an electro-hydraulic lithotriptor device that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's center while the probe is irrigated with a saline solution.

The device is manufactured by R. Wolf Medical Instruments Corp. and is classified as a Class II medical device with product code FFK. It is authorized under FDA 510(k) clearance with number K822644, received on September 1, 1982, and decided on September 21, 1982. The device is reviewed under the Gastroenterology, Urology advisory committee.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822644 Date21 Sep 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FFK
Device Class
Class II
Regulation
21 CFR Part 876.4480
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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