510(k) · Cleared
ClearedSurgical Direct Hand-held Laparoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Direct, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 20, 2019 as substantially equivalent to K151567 (Endoplus, 2015) after a 52-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Dec 20, 2019
- Review
- 52 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935270 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
- 3 generations backK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
- 2 generations backK062072 Pajunks Disposable Inserts for Handle Instruments and HF ElectrodesPAJUNK GmbH Medizintechnologie · 2006
- 1 generation backK151567 ENDOPLUS hand-held laparoscopic instrumentsEndoplus · 2015
- This deviceK193018 Surgical Direct Hand-held Laparoscopic InstrumentsSurgical Direct, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935270 | Modular Forcep and Scissor System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −3 | K033249 | Pajunk Modular Handle Instruments | Pajunk GmbH | 2004 | — |
| −2 | K062072 | Pajunks Disposable Inserts for Handle Instruments and HF Electrodes | PAJUNK GmbH Medizintechnologie | 2006 | — |
| −1 | K151567 | ENDOPLUS hand-held laparoscopic instruments | Endoplus | 2015 | — |
| 0 (this device) | K193018 | Surgical Direct Hand-held Laparoscopic Instruments | Surgical Direct, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K151567 | ENDOPLUS hand-held laparoscopic instrumentsSummary page 4…Class II PREDICATE DEVICE; Manufacturer Brand Name 510(k) Number ENDOPLUS ENDOPLUS Hand-held K151567 Laparoscopic Instruments K193018… | 2015 |
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 25 years and passes through 5 companies; a new generation was cleared every 9.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Surgical Direct Hand-held Laparoscopic Instruments are intended for grasping, cutting, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscope during laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.
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/K193018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193018: Surgical Direct Hand-held Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193018
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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