510(k) · Cleared
ClearedFisso Holding System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baitella AG · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 22, 2007 as substantially equivalent to K050051 (KLS-Martin L.P., 2005) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 22, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945572 (1995). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- 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 deviceK070509 Fisso Holding SystemBaitella AG · 2007
- Descendant · cites it directly · 2 of its ownK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
- Descendant · 2 generations on · 0 of its ownK240506 KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK232405 Endofix ExoAktormed GmbH · 2024
- Descendant · cites it directly · 0 of its ownK100442 Fastclamp Endoscopic Clamping SystemSurgical Innovations Group Plc · 2010
Most influential descendants
Showing 4 of 4 · See all- K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019 · cites it directly2descendants
- K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024 · 2 generations on0descendants
- K232405Endofix ExoAktormed GmbH · 2024 · 2 generations on0descendants
- K100442Fastclamp Endoscopic Clamping SystemSurgical Innovations Group Plc · 2010 · cites it directly0descendants
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) | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| +1 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019 | — |
| +2 | K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024 | — |
| +2 | K232405 | Endofix Exo | Aktormed GmbH | 2024 | — |
| +1 | K100442 | Fastclamp Endoscopic Clamping System | Surgical Innovations Group Plc | 2010 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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…e Name Manufacturer K-No. Devices: Armand Endoscope 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 Endoscope 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…re K992006 300-33 LLC. Abdominal Wall Retractor Omni-Tract Surgical K950214 FISSO Holding System is substantially equivalent to the predicate devices since the basic feature… | 1995 |
What descends from it? (4)
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 12 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.
- Of its descendants, K190576 (Biomet Microfixation, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K050051.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
FISSO Holding System consists of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 4mm 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/K070509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070509: Fisso Holding System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070509
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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