510(k) · Cleared
ClearedAckermann Surgical Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackermann Instrumente GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 21, 1998 as substantially equivalent to K932540 (Advanced Surgical, Inc., 1994) after a 151-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Apr 21, 1998
- Review
- 151 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932540 (1994). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK932540 Laporascopic Surgical Instruments /General UseAdvanced Surgical, Inc. · 1994
- This deviceK974382 Ackermann Surgical InstrumentsAckermann Instrumente GmbH · 1998
- Descendant · cites it directly · 2 of its ownK051073 Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK103840 Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical…Flexbar Machine Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK093785 Modular EndoscopeSialo Technology, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK082735 Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK060233 Trokamed GMBH Endoscopes and AccessoriesTrokamed GmbH · 2006
Most influential descendants
Showing 5 of 5 · See all- K051073Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006 · cites it directly2descendants
- K103840Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical HandleFlexbar Machine Corp. · 2011 · cites it directly0descendants
- K093785Modular EndoscopeSialo Technology, Ltd. · 2010 · 2 generations on0descendants
- K082735Stone Grasping Basket, Model PD-T1 2115Sialo Technology, Ltd. · 2009 · 2 generations on0descendants
- K060233Trokamed GMBH Endoscopes and AccessoriesTrokamed GmbH · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932540 | Laporascopic Surgical Instruments /General Use | Advanced Surgical, Inc. | 1994 | — |
| 0 (this device) | K974382 | Ackermann Surgical Instruments | Ackermann Instrumente GmbH | 1998 | — |
| +1 | K051073 | Midiview Series of Microendoscopes | Millennium Devices, Inc. | 2006 | — |
| +1 | K103840 | Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical Handle | Flexbar Machine Corp. | 2011 | — |
| +2 | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
| +2 | K082735 | Stone Grasping Basket, Model PD-T1 2115 | Sialo Technology, Ltd. | 2009 | — |
| +1 | K060233 | Trokamed GMBH Endoscopes and Accessories | Trokamed GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 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? (1)
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 |
|---|---|---|---|
| * | K932540 | Laporascopic Surgical Instruments /General UseSummary page 1…54 Laparoscope and accessories, general and plastic surgery Common/Usual Name: Endoscope and accessories, endoscopic surgical instruments, etc. Proprietary name: (K932540), and Device description: and minimally accessories. Intended use: cavities, diagnostic and Technological Instruments instrum… | 1994 |
What descends from it? (5)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K051073 (Millennium Devices, Inc., 2006) has gone furthest, with 2 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 | — |
What is it indicated for?
The device is intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974382: Ackermann Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974382
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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