510(k) Report

510(k) · Cleared

Cleared

Veroscope Optical Veress Cannula & Dilation Tube System

K041321510(k) TraditionalCleared Jul 9, 200452-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 Jul 9, 2004 as substantially equivalent to K962799 (Richard Wolf GmbH, 1996) and 5 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.

Decided
Jul 9, 2004
Review
52 days
Class
Class II
Product code
HET
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K940232 (1994). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1994: 2 other ancestors1995: 3 other ancestors2006: 1 descendant clearedK940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 1994K961940 · Innerdyne Step Trocar Expandable Port, Onestep · Innerdyne, Inc. · 1996 · recalledK012539 · Verastep · United States Surgical, A Division of Tyco Healthc · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor3 generations back: 3 other ancestors 1 generation forward: 1 descendant K012539 · Verastep · United States Surgical, A Division of Tyco Healthc · 2001K961940 · Innerdyne Step Trocar Expandable Port, Onestep · Innerdyne, Inc. · 1996 · recalledK940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 19940
  1. Root · 3 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
  2. 2 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
  3. 1 generation backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
  4. This deviceK041321 Veroscope Optical Veress Cannula & Dilation Tube SystemRichard Wolf Medical Instruments Corp. · 2004
  5. Descendant · cites it directly · 0 of its ownK062097 Veress Cannula and Modular Veress CannulaPAJUNK GmbH Medizintechnologie · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K062097Veress Cannula and Modular Veress CannulaPAJUNK GmbH Medizintechnologie · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K940232Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc.1994—
−2K961940Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc.19961
−1K012539VerastepUnited States Surgical, A Division of Tyco Healthc2001—
0 (this device)K041321Veroscope Optical Veress Cannula & Dilation Tube SystemRichard Wolf Medical Instruments Corp.2004—
+1K062097Veress Cannula and Modular Veress CannulaPAJUNK GmbH Medizintechnologie2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199530
199610
199710
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K041321, 1994–2006Source: 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? (7)

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
*K962799Miniature Laparoscope Set (Mini Lap)
Summary page 1
…Information on devices to which substantial equivalence is claimed: 5 10(k) Number Trade or proprietary or model name Manufacturer I K962799 I Set Laparoscopy, Veress Cannula spring IRichard Wolf loaded, Telescopes 2K971420…
Richard Wolf GmbH1996—
*K971420Microendoscope (8755.401,411,461,451)/External Sheath (8755.221,222)/Veress Cannula…
Summary page 1
…ame Manufacturer I K962799 I Set Laparoscopy, Veress Cannula spring IRichard Wolf loaded, Telescopes 2K971420 2 Mini Laparoscopes, Veress Cannula spring 2 Richard Wolf loaded, Telescopes 3K00341…
Richard Wolf Medical Instruments Corp.1997—
*K003417Mini Fiber Endoscopes; Outer Sheaths; Veress Cannulas; Veress Cannulas with Outer…
Summary page 1
…loaded, Telescopes 2K971420 2 Mini Laparoscopes, Veress Cannula spring 2 Richard Wolf loaded, Telescopes 3K003417 3 Mini Fiber Laparoscope/ Hysteroscope Sets 3 Richard Wolf 4 K942201 4 Laparoscopy dilation system…
Richard Wolf Medical Instruments Corp.2001—
*K942201Laparoscopy Dilation System
Summary page 1
…nnula spring 2 Richard Wolf loaded, Telescopes 3K003417 3 Mini Fiber Laparoscope/ Hysteroscope Sets 3 Richard Wolf 4 K942201 4 Laparoscopy dilation system 4 Richard Wolf 5not known 5 Optical VERESS Pneumoperitoneum…
Richard Wolf Medical Instruments Corp.1994—
*K983925Endopath Ultra Veress Needle
Summary page 1
…K942201 4 Laparoscopy dilation system 4 Richard Wolf 5not known 5 Optical VERESS Pneumoperitoneum Needle 5 Karl Storz 6 K983925 6 EndoPath Ultra Veress Insufflation Needle 6 Ethicon Endo-Surgery, Inc. 7 K012539 7 VersaStep System…
Ethicon Endo-Surgery, Inc.1999—
*K012539Verastep
Summary page 1
…5 Optical VERESS Pneumoperitoneum Needle 5 Karl Storz 6 K983925 6 EndoPath Ultra Veress Insufflation Needle 6 Ethicon Endo-Surgery, Inc. 7 K012539 7 VersaStep System 7 U.S. Surgical (Tyco Health)…
United States Surgical, A Division of Tyco Healthc2001—
*—Optical VERESS Pneumoperitoneum Needle
Named without a submission number
—

Also cleared against K962799: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K062097Veress Cannula and Modular Veress CannulaPAJUNK GmbH Medizintechnologie20060

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?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K062097 (PAJUNK GmbH Medizintechnologie, 2006) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K962799.

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 VEROSCOPE is used percutaneously for penetrating the abdominal cavity under endoscopic control to safely reach a defined body region. It therefore also serves to create a pneumoperitoneum under visual control in the abdomen.

The Dilation Tube System and standard Dilation System is used for dilating surgically created passages in body cavities.

The Veroscope and dilation tube systems are used for diagnosis and therapy in conjunction with endoscopic accessories in various disciplines such as surgery, gynecology and urology.

Indications for use as stated in the FDA summary.

Also cleared against K962799

2 other devices cite the same predicate.

  • K982623Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
  • K971420Microendoscope (8755.401,411,461,451)/External Sheath (8755.221,222)/Veress Cannula (8755.211,212)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/K041321 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041321: Veroscope Optical Veress Cannula & Dilation Tube System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041321

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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