510(k) · Cleared
ClearedCurved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical Handle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexbar Machine Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 28, 2011 as substantially equivalent to K974382 (Ackermann Instrumente GmbH, 1998) after an 80-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 28, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932540 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK932540 Laporascopic Surgical Instruments /General UseAdvanced Surgical, Inc. · 1994
- 1 generation backK974382 Ackermann Surgical InstrumentsAckermann Instrumente GmbH · 1998
- This deviceK103840 Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical…Flexbar Machine Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932540 | Laporascopic Surgical Instruments /General Use | Advanced Surgical, Inc. | 1994 | — |
| −1 | K974382 | Ackermann Surgical Instruments | Ackermann Instrumente GmbH | 1998 | — |
| 0 (this device) | K103840 | Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical Handle | Flexbar Machine Corp. | 2011 | — |
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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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 |
|---|---|---|---|
| * | K974382 | Ackermann Surgical InstrumentsSummary page 1…ope, General & Plastic Surgery GEI, 2ICFR 878.4400 Electrosurgical, Cutting & Coagulation & Accessories PREDICATE DEVICE: Ackermaun instruniente - K974382; Laparoscope Scissor Tips and Handle DESCRIPTION: The Laparoscopic Scissor Tips are accessory disposable components that attach… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K974382.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The disposable Laparoscopic Scissor Tips and reuseable Handle are used in electrical and non-electrosurgicat procedures intended for providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103840 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103840: Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103840
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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