510(k) · Cleared
Recalled · 2011Assisto Arm Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geomed Medizin-Technik GmbH & Co. · GWG Endoscope, Neurological
Cleared on Nov 23, 2005 as substantially equivalent to K050051 (KLS-Martin L.P., 2005) and 2 other predicates after a 54-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Nov 23, 2005
- Review
- 54 days
- Class
- Class II
- Product code
- GWG
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945572 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
- 2 generations backK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- 1 generation backK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- This deviceK052745 Assisto Arm SystemsGeomed Medizin-Technik GmbH & Co. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945572 | Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −2 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| −1 | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| 0 (this device) | K052745 | Assisto Arm Systems | Geomed Medizin-Technik GmbH & Co. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1999 | 1 | 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 GWG? 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 GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050051 | Armand Endoscope HolderSummary page 1…ate Name Manufacturer K-Na. Devices: Armand Endloscope Holder KLS-Martin L.P. K050051 Neuroview Instrument Holder, Model Integra Neurocare K992006 300-33… | 2005 |
| * | K992006 | Neuroview Instrument Holder, Model 300-33Summary page 1…Armand Endloscope Holder KLS-Martin L.P. K050051 Neuroview Instrument Holder, Model Integra Neurocare K992006 300-33 LLC. Abdominal Wall Retractor Omni… | 1999 |
| * | K950214 | Abdominal Wall RetractorSummary page 1…care K992006 300-33 LLC. Abdominal Wall Retractor Omni-Tract Surgical K950214 ASSISTO®D Arm Systems are substantially equivalent to the predicate devices since the basic feat… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2011 | Not classified | Z-1061-2012 | Nonconforming Material/Component | The product may fracture during surgical procedures. |
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 4.5 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K050051.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052745 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052745: Assisto Arm Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052745
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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