510(k) Report

510(k) · Cleared

Cleared

Riwo Cut-Morcellator Existing of Knife/Cutting Sleeve/Protection Sleeve/Claw Grasping Forceps

K970105510(k) TraditionalCleared Mar 4, 199750-day reviewClass II21 CFR 884.1720

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corp. · HET Laparoscope, Gynecologic (And Accessories)

Cleared on Mar 4, 1997 as substantially equivalent to K942201 (Richard Wolf Medical Instruments Corp., 1994) after a 50-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.

Decided
Mar 4, 1997
Review
50 days
Class
Class II
Product code
HET
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K942201 (1994). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2024: 1 descendant clearedK942201 · Laparoscopy Dilation System · Richard Wolf Medical Instruments Corp. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants K942201 · Laparoscopy Dilation System · Richard Wolf Medical Instruments Corp. · 19940
  1. Root · 1 generation backK942201 Laparoscopy Dilation SystemRichard Wolf Medical Instruments Corp. · 1994
  2. This deviceK970105 Riwo Cut-Morcellator Existing of Knife/Cutting Sleeve/Protection…Richard Wolf Medical Instruments Corp. · 1997
  3. Descendant · cites it directly · 6 of its ownK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
  4. Descendant · 2 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
  5. Descendant · 2 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
  6. Descendant · 3 generations on · 0 of its ownK260884 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  7. Descendant · 3 generations on · 0 of its ownK251923 Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12011: 12020: 12023: 12024: 12026: 2
2004high 2 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all
  • K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004 · cites it directly6descendants
  • K192499Cyber BladeSIDAM S.r.l. · 2020 · 2 generations on2descendants
  • K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 2 generations on1descendant
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026 · 3 generations on0descendants
  • K251923Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K942201Laparoscopy Dilation SystemRichard Wolf Medical Instruments Corp.1994—
0 (this device)K970105Riwo Cut-Morcellator Existing of Knife/Cutting Sleeve/Protection Sleeve/Claw…Richard Wolf Medical Instruments Corp.1997—
+1K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp.2004—
+2K192499Cyber BladeSIDAM S.r.l.2020—
+2K213597MultiCut SoloAsclepion Laser Technologies GmbH2023—
+3K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG2026—
+3K251923Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201110
202010
202310
202410
202620
FIG. 1 — Lineage of K970105, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HET device

  1. #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K942201Laparoscopy Dilation System
Summary page 1
…caps 1 Richard Wolf 8383.16 2 Serrated Edged Macro-Morcellator-Set 15/5, |2 Wisap type-no. 7674-1 3 STEINER Electromechanic Morceliator, 3 Karl Storz type-no. 26712811 4 K942201 |4 Trocar Sleeve System ________ }4Richard Wolf 1.0 Description The RIWO CUT-Morcellator 8386.205 is a manually operated rotary…
Richard Wolf Medical Instruments Corp.1994—
*—Palmer grasping and biopsy forceps 8383.16
Named without a submission number
—
*—Serrated Edged Macro-Morcellator-Set 15/5, type-no. 7674-1
Named without a submission number
—
*—STEINER Electromechanic Morcellator, type-no. 26712811
Named without a submission number
—

Also cleared against K942201: 2 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp.20046

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K041610 (Richard Wolf Medical Instruments Corp., 2004) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K942201.

How does its category compare?

All HET devices

HET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HET

2in 2025

2008: 32009: 12010: 12011: 22012: 22013: 22015: 22017: 22018: 12019: 22020: 22021: 42022: 12025: 2
2007high 4 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HET

269in 2021

2008: 176 days median2021: 269 days median
2007high 269 (2021) · low 176 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HET

4in 2023

2008: 42009: 12015: 12022: 12023: 4
2007high 4 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HET

4,513in 2025

2007: 1812008: 3592009: 4032010: 2142011: 4172012: 1,1182013: 1,0352014: 1752015: 1242016: 2052017: 892018: 532019: 442020: 492021: 1322022: 2162023: 8242024: 3,4962025: 4,513
2007high 4,513 (2025) · low 44 (2019)2025

MAUDE reports naming product code HET, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0181
200831764359
20091—1403
20101—0214
20112—0417
20122—01,118
20132—01,035
20140—0175
20152—1124
20160—0205
20172—089
20181—053
20192—044
20202—049
202142690132
20221—1216
20230—4824
20240—03,496
20252—04,513
20260—0—

What is it indicated for?

The RIWO CUT-Morcellator is used in gynecologic and surgical laparoscopic procedures to shred large pieces of tissue and to remove myomata or other tissue by means of a manually operated tubular knife.

Severed tissue like myoma, uterus or cysts can be grasped by a forceps, morcellated, and extracted.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K942201

2 other devices cite the same predicate.

  • K041321Veroscope Optical Veress Cannula & Dilation Tube SystemRichard Wolf Medical Instruments Corp. · 2004
  • K973737Mini Trocar Sleeve and Trocars 3.5 MM, Micro Trocar Sleeve and Trocars 2 MM, Dilatation Sleeve and Guide Rod…Richard Wolf Medical Instruments Corp. · 1997

More from Richard Wolf Medical Instruments Corp.

146 FDA decisions under this applicant name. See the company

  • P870080/S002Hulka Clip for Tubal OcclusionRichard Wolf Medical Instruments Corp. · 2016
  • K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar…Richard Wolf Medical Instruments Corp. · 2012

Recent decisions in HET

The HET category page

  • K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited · 2025
  • K243821i-CutA.M.I. Agency For Medical Innovations GmbH · 2025
  • K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited · 2022
  • K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2021
  • K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp. · 20211 recall

https://510kreport.com/device/K970105 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970105: Riwo Cut-Morcellator Existing of Knife/Cutting Sleeve/Protection Sleeve/Claw Grasping Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970105

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026