510(k) · Cleared
ClearedCircon Acmi Gen Surg Instru for Mini Invasive Surg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Video · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 15, 1993 after a 443-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 15, 1993
- Review
- 443 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK914883 Circon Acmi Gen Surg Instru for Mini Invasive SurgCircon Video · 1993
- Descendant · cites it directly · 1 of its ownK062337 Modular Laparoscopy Accessories, Handle; Sissors (Straight and…Aaron Medical Industries · 2006
- Descendant · cites it directly · 1 of its ownK014158 Endoscopic Camera TC804/C4World of Medicine Lemke GmbH · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK081431 Meg Laparoscopic ElectrodesBovie Medical · 2008
- Descendant · 2 generations on · 0 of its ownK032544 VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin) · 2003
- Descendant · cites it directly · 0 of its ownK991416 Endoscopic CameraGenzyme Surgical Product (Genzyme Biosurgery) · 1999
Most influential descendants
Showing 5 of 5 · See all- K062337Modular Laparoscopy Accessories, Handle; Sissors (Straight and Curved); Grasper…Aaron Medical Industries · 2006 · cites it directly1descendant
- K014158Endoscopic Camera TC804/C4World of Medicine Lemke GmbH · 2002 · cites it directly1descendant
- K081431Meg Laparoscopic ElectrodesBovie Medical · 2008 · 2 generations on0descendants
- K032544VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin) · 2003 · 2 generations on0descendants
- K991416Endoscopic CameraGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914883 | Circon Acmi Gen Surg Instru for Mini Invasive Surg | Circon Video | 1993 | — |
| +1 | K062337 | Modular Laparoscopy Accessories, Handle; Sissors (Straight and Curved)… | Aaron Medical Industries | 2006 | — |
| +1 | K014158 | Endoscopic Camera TC804/C4 | World of Medicine Lemke GmbH | 2002 | 1 |
| +2 | K081431 | Meg Laparoscopic Electrodes | Bovie Medical | 2008 | — |
| +2 | K032544 | VP-1000; Med Cam 100; VP-3000A; Med Cam 300 | Mgb Endoskopische Gerate GmbH (Berlin) | 2003 | — |
| +1 | K991416 | Endoscopic Camera | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K062337 (Aaron Medical Industries, 2006) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K914883 · printed Nov 5, 2026
Cite this page
510(k) Report. “K914883: Circon Acmi Gen Surg Instru for Mini Invasive Surg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K914883
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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