510(k) Report

510(k) · Cleared

Cleared

Neuroview Instrument Holder, Model 300-33

K992006510(k) TraditionalCleared Aug 17, 199963-day reviewClass II21 CFR 876.1500

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

Integra Neurocare, LLC · OCV Endoscope Holder

Cleared on Aug 17, 1999 as substantially equivalent to K990334 (KARL STORZ Endoscopy-America, Inc., 1999) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.

Decided
Aug 17, 1999
Review
63 days
Class
Class II
Product code
OCV
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K945572 (1995). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1995: 1 other ancestor2005: 2 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2010: 2 descendants cleared2019: 1 descendant cleared2009: 1 descendant cleared2024: 2 descendants clearedK945572 · Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 · Johnson & Johnson Professionals, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K945572 · Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 · Johnson & Johnson Professionals, Inc. · 19950
  1. Root · 1 generation backK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
  2. This deviceK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
  3. Descendant · cites it directly · 9 of its ownK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
  4. Descendant · cites it directly · 4 of its ownK070509 Fisso Holding SystemBaitella AG · 2007
  5. Descendant · 2 generations on · 2 of its ownK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
  6. Descendant · 2 generations on · 2 of its ownK061292 Statarius, Model 001 003Kinetic Surgical, LLC · 2006
  7. Descendant · 3 generations on · 1 of its ownK093616 V. Mueller Camera Controller with Storage CartCarefusion 2200 · 2009

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 12009: 12010: 22019: 12024: 2
2005high 2 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • K050051Armand Endoscope HolderKLS-Martin L.P. · 2005 · cites it directly9descendants
  • K070509Fisso Holding SystemBaitella AG · 2007 · cites it directly4descendants
  • K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019 · 2 generations on2descendants
  • K061292Statarius, Model 001 003Kinetic Surgical, LLC · 2006 · 2 generations on2descendants
  • K093616V. Mueller Camera Controller with Storage CartCarefusion 2200 · 2009 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945572Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc.1995—
0 (this device)K992006Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC1999—
+1K050051Armand Endoscope HolderKLS-Martin L.P.2005—
+1K070509Fisso Holding SystemBaitella AG2007—
+2K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation2019—
+2K061292Statarius, Model 001 003Kinetic Surgical, LLC2006—
+3K093616V. Mueller Camera Controller with Storage CartCarefusion 22002009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200710
200910
201020
201910
202420
FIG. 1 — Lineage of K992006, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 OCV? 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 OCV device

  1. #1 K240506 KARL STORZ Holdersscore 9.4 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K990334Ksea Endoscope Holder
Summary page 4
…e Neuroview® Instrument Holder (Model 300-33) is substantially equivalent to the following currently marketed instruments or endoscopc holders: e KSEA Endoscope Holder (K990334) e Codman Rigid and Steerable Endoscope Holders (K945572) e Leonard Arm-Support Arm-Endoscope Accessory (K951854) TOTAL P.@3 =…
KARL STORZ Endoscopy-America, Inc.1999—
*K945572Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352
Summary page 4
…ially equivalent to the following currently marketed instruments or endoscopc holders: e KSEA Endoscope Holder (K990334) e Codman Rigid and Steerable Endoscope Holders (K945572) e Leonard Arm-Support Arm-Endoscope Accessory (K951854) TOTAL P.@3 Summary of Safety and Effectiveness Page2 o…
Johnson & Johnson Professionals, Inc.1995—
*K951854Leonard Arm - Support Arm - Endoscopic Accessory
Summary page 4
…ruments or endoscopc holders: e KSEA Endoscope Holder (K990334) e Codman Rigid and Steerable Endoscope Holders (K945572) e Leonard Arm-Support Arm-Endoscope Accessory (K951854) TOTAL P.@3 Summary of Safety and Effectiveness Page2 of 2 Device Description: The Neuroview® Instrument Holder…
Leonard Medical, Inc.1995—

Also cleared against K990334: 4 other devices →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050051Armand Endoscope HolderKLS-Martin L.P.20059
K070509Fisso Holding SystemBaitella AG20074
K052745Assisto Arm SystemsGeomed Medizin-Technik GmbH & Co.20050

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K050051 (KLS-Martin L.P., 2005) has gone furthest, with 9 descendants of its own.
  • 4 other devices also cite its predicate K990334.

How does its category compare?

All OCV devices

OCV Endoscope Holder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCV

2in 2024

2009: 12010: 12019: 12024: 2
2007high 2 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCV

Too few OCV 510(k)s in any year since 2007 to give a median.

Recalls per year · OCV

No recall names OCV since 2007.

Adverse event reports per year · OCV

1in 2025

2015: 12023: 22024: 12025: 1
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCV, 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—00
20080—00
20091—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—02
20242—01
20250—01
20260—0—

What is it indicated for?

Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.

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 K990334

4 other devices cite the same predicate.

  • K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
  • K051979Ors Model 6000 Endoscope HolderO.R. Solutions, Inc. · 2005
  • K050051Armand Endoscope HolderKLS-Martin L.P. · 2005
  • K024251SightfixWorld of Medicine Lemke GmbH · 2003

More from Integra Neurocare, LLC

12 FDA decisions under this applicant name. See the company

  • K002392Ventrix True Tech Ventricular Tunneling Pressure Monitoring Kit, Model NL960-VIntegra Neurocare, LLC · 2000
  • K981246Beverly Referential Valve (NL850-9710) with Integral Peritoneal Catheter (NL850-9720) Valve Kit (NL850-9730)Integra Neurocare, LLC · 1999
  • K973525Maurice Worldwide Shunt SystemIntegra Neurocare, LLC · 1997
  • K972994External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997
  • K972261Rivetti-Levinson Instraluminal ShuntIntegra Neurocare, LLC · 1997

Recent decisions in OCV

The OCV category page

  • K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024
  • K232405Endofix ExoAktormed GmbH · 2024
  • K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
  • K102179Enview (TM)Carefusion 2200 · 2010
  • K093616V. Mueller Camera Controller with Storage CartCarefusion 2200 · 2009

https://510kreport.com/device/K992006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992006: Neuroview Instrument Holder, Model 300-33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992006

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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