510(k) · Cleared
ClearedReposable Instrument System, Models MF001-MF083
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 21, 2002 as substantially equivalent to K980758 (Microline Pentax, Inc., 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1993. 8 later devices descend from it.
- Decided
- Mar 21, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932648 (1993). 8 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 3 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 2 generations backK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
- 1 generation backK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- This deviceK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- Descendant · 2 generations on · 4 of its ownK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- Descendant · 4 generations on · 2 of its ownK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK100109 Logiflex Laparoscopic Band Positioning DeviceSurgical Innovations Plc · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006 · cites it directly7descendants
- K090583Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009 · 2 generations on4descendants
- K141058Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014 · 3 generations on3descendants
- K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015 · 4 generations on2descendants
- K100109Logiflex Laparoscopic Band Positioning DeviceSurgical Innovations Plc · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −3 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −2 | K970826 | Selecta-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1997 | — |
| −1 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| 0 (this device) | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| +1 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| +2 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| +3 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
| +4 | K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2015 | — |
| +2 | K100109 | Logiflex Laparoscopic Band Positioning Device | Surgical Innovations Plc | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K980758 | 3 MM Selec-Tip Laparoscopic Scissors Our OCR of the scanned summary read K580758, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “3 MM Select-Tip Laparoscopic Instrument System”. | 1998 |
| * | K970826 | Selecta-Tip Laparoscopic ScissorsSummary page 1…g principles to the following predicate devices: « Microline: ' « 3 MM Selsc-Tip Laparoscopic Instrument System (KS80758) « “Selecta-tip” Laparoscopic Instrument System (K970826) « Weck’s Endoscopic Instrument System (Disposable/Reusable) (K926203) w e, + % é DEPARTMENT OF HEALTH & HUMAN S… | 1997 |
| * | K926203 | Endoscopic Scissors (Disposable/Reusable Shafts)Summary page 1…Selsc-Tip Laparoscopic Instrument System (KS80758) « “Selecta-tip” Laparoscopic Instrument System (K970826) « Weck’s Endoscopic Instrument System (Disposable/Reusable) (K926203) w e, + % é DEPARTMENT OF HEALTH & HUMAN SERVICES » . Public Health Service o WEALTY Py ", <, . %"K 5. . . Foo… | 1993 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063485 | Logic Laparoscopic Scissors | 2006 | 7 |
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 9 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K063485 (Surgical Innovations Plc, 2006) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K980758.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Aesculap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laproscopic general, vascular, gynecological, and thoracic 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/K014207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014207: Reposable Instrument System, Models MF001-MF083.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014207
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026