510(k) · Cleared
ClearedKS Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric General Endospocic and Laparoscopic Surgical Pros
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 18, 1995 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Jan 18, 1995
- Review
- 30 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK946164 KS Semi-Rigid Micro-Endoscopes and Accessories for Adult and…KARL STORZ Endoscopy-America, Inc. · 1995
- Descendant · cites it directly · 17 of its ownK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- Descendant · 2 generations on · 13 of its ownK123102 Sovereign MiniAesculap, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK173919 HX DeviceHuman Extension, Ltd. · 2018
- Descendant · 4 generations on · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K982623Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998 · cites it directly17descendants
- K123102Sovereign MiniAesculap, Inc. · 2013 · 2 generations on13descendants
- K173919HX DeviceHuman Extension, Ltd. · 2018 · 3 generations on8descendants
- K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · 4 generations on3descendants
- K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946164 | KS Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric General… | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +1 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| +2 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| +3 | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| +4 | K203603 | Monopolar Hook | Human Xtensions, Ltd. | 2021 | — |
| +3 | K143299 | Percuvance (R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982623 | Aesculap Needlescopic Instrument System | 1998 | 17 |
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?
- Of its descendants, K982623 (Aesculap, Inc., 1998) has gone furthest, with 17 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 | — |
https://510kreport.com/device/K946164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K946164: KS Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric General Endospocic and Laparoscopic Surgical Pros.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K946164
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026