# K984521: Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Mar 17, 1999 after 86 days
- Product code: EQL (Laryngostroboscope)
- Device class: 1
- Regulation: 21 CFR 874.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871250 (1987). 5 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970088: Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1:, Richard Wolf Medical Instruments Corp. (1997) Summary page 1.
- K972584: Stryker Hummer II Microdebrider System, Stryker Endoscopy (1997) Summary page 1.
- K973499: XPS Straightshot Microbrider System or Trebay Shaver System, Xomed, Inc. (1998) Summary page 1.
- K953370: Karl Storz Ent Shaver, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 1.

## Most influential descendants
- K030082: Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 (2003), 8 descendants of its own
- K041610: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 (2004), 6 descendants of its own
- K192499: Cyber Blade (2020), 2 descendants of its own
- K213597: MultiCut Solo (2023), 1 descendant of its own
- K260884: UNIDRIVE Select System (2026), 0 descendants of its own

## Indications for use
The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions. Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation. For therapy with endoscopic accessories: • in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures. • thoracic surgery, e.g. for removing hematomas • sinus surgery (ENT), e.g. for removing polyps or cysts. In certain cases, bone structures are removed or trimmed. • spine surgery (arthroscopic micro disectomy (AMD), spinal endendoscopsy) e.g. removal of pathological tissue.

Source page: https://510kreport.com/device/K984521
Methodology: https://510kreport.com/methodology