510(k) · Cleared
ClearedAbdominal Wall Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni-Tract Surgical, Div. Minn. Scientific, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 6, 1995 after an 18-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 6, 1995
- Review
- 18 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK950214 Abdominal Wall RetractorOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 1995
- Descendant · cites it directly · 4 of its ownK070509 Fisso Holding SystemBaitella AG · 2007
- Descendant · 2 generations on · 2 of its ownK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
- Descendant · 3 generations on · 0 of its ownK240506 KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK232405 Endofix ExoAktormed GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK100442 Fastclamp Endoscopic Clamping SystemSurgical Innovations Group Plc · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070509Fisso Holding SystemBaitella AG · 2007 · cites it directly4descendants
- K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019 · 2 generations on2descendants
- K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024 · 3 generations on0descendants
- K232405Endofix ExoAktormed GmbH · 2024 · 3 generations on0descendants
- K100442Fastclamp Endoscopic Clamping SystemSurgical Innovations Group Plc · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950214 | Abdominal Wall Retractor | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 1995 | — |
| +1 | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| +2 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019 | — |
| +3 | K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024 | — |
| +3 | K232405 | Endofix Exo | Aktormed GmbH | 2024 | — |
| +2 | K100442 | Fastclamp Endoscopic Clamping System | Surgical Innovations Group Plc | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K070509 (Baitella AG, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K950214 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950214: Abdominal Wall Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950214
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026