510(k) · Cleared
ClearedWalterLorenz Surgical Assist Arm Scope Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation · OCV Endoscope Holder
Cleared on Jun 5, 2019 as substantially equivalent to K990334 (KARL STORZ Endoscopy-America, Inc., 1999) and 1 other predicate after a 91-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 5, 2019
- Review
- 91 days
- Class
- Class II
- Product code
- OCV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945572 (1995). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
- 3 generations backK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- 2 generations backK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- 1 generation backK070509 Fisso Holding SystemBaitella AG · 2007
- This deviceK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
- Descendant · cites it directly · 0 of its ownK240506 KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK232405 Endofix ExoAktormed GmbH · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945572 | Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| −2 | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| −1 | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| 0 (this device) | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019 | — |
| +1 | K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024 | — |
| +1 | K232405 | Endofix Exo | Aktormed GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
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 K240506 KARL STORZ Holdersscore 9.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990334 | Ksea Endoscope HolderSummary page 5…general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning. Predicate Devices: Primary Predicate: K990334, KSEA (Karl Storz) Endoscope Holder Secondary Predicate: K070509, Fisso Holding Arm The similarities of the subject device to th… | 1999 |
| * | K070509 | Fisso Holding SystemSummary page 5…also be used for instrument holding, retraction, and positioning. Predicate Devices: Primary Predicate: K990334, KSEA (Karl Storz) Endoscope Holder Secondary Predicate: K070509, Fisso Holding Arm The similarities of the subject device to the predicate devices are as follows: The indications for use… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K240506 (Karl Storz Endoscopy America, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K990334.
How does its category compare?
All OCV devicesOCV Endoscope Holder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OCV
2in 2024
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
MAUDE reports naming product code OCV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic and therapeutic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190576 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190576: WalterLorenz Surgical Assist Arm Scope Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190576
Report an extraction error
Are you the manufacturer?
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