510(k) · Cleared
ClearedSovereign Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 3, 2013 as substantially equivalent to K982623 (Aesculap, Inc., 1998) after a 93-day review. Its family tree reaches back 3 generations to 1991. 13 later devices descend from it.
- Decided
- Jan 3, 2013
- Review
- 93 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912544 (1991). 11 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 2 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 1 generation backK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- This deviceK123102 Sovereign MiniAesculap, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK173919 HX DeviceHuman Extension, Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK153063 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK260183 MediBot Needle Driver UnoParallel Robotics, LLC · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173919HX DeviceHuman Extension, Ltd. · 2018 · cites it directly8descendants
- K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · 2 generations on3descendants
- K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · cites it directly2descendants
- K153063Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · 2 generations on1descendant
- K260183MediBot Needle Driver UnoParallel Robotics, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −2 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −1 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| 0 (this device) | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| +1 | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| +2 | K203603 | Monopolar Hook | Human Xtensions, Ltd. | 2021 | — |
| +1 | K143299 | Percuvance (R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015 | 2 |
| +2 | K153063 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2016 | 9 |
| +2 | K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K982623 | Aesculap Needlescopic Instrument SystemSummary page 1…, Inc. believes that the modified components of the Sovereigns mini system are substantially equivalent to the components of the Aesculap Needlescopic Instrument System (K982623). DEVICE DESCRIPTION Aesculap's Sovereign® mini system can be used in adult and pediatric laparoscopic general surgery. The sys… | 1998 |
What descends from it? (13)
See all 133 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K173919 (Human Extension, Ltd., 2018) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K982623.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
Aesculap's Sovereign® mini system is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123102: Sovereign Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123102
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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