510(k) · Cleared
ClearedOmnisonics Flexible Fiber Optic Endoscope and Coupler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnisonics Medical Technologies · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 12, 1999 as substantially equivalent to K962116 (Galileo Electro-Optics Corp., 1996) and 4 other predicates after an 82-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 82 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K912089 (1991). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK912089 Modified Series 2100 EndoscopesMedical Laser, Inc. · 1991
- 1 generation backK962255 Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc. · 1996
- This deviceK991377 Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999
- Descendant · cites it directly · 0 of its ownK080780 Anchorage Scope, Model 000003Epitek, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK993445 Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912089 | Modified Series 2100 Endoscopes | Medical Laser, Inc. | 1991 | — |
| −1 | K962255 | Clarus Murphypen Endoscope (2127-XXX) | Clarus Medical Systems, Inc. | 1996 | — |
| 0 (this device) | K991377 | Omnisonics Flexible Fiber Optic Endoscope and Coupler | Omnisonics Medical Technologies | 1999 | — |
| +1 | K080780 | Anchorage Scope, Model 000003 | Epitek, Inc. | 2008 | — |
| +1 | K993445 | Omnisonic Endoscopic Deflector | Omnisonics Medical Technologies | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 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? (5)
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 |
|---|---|---|---|
| * | K962116 | Galileo EndoscopesSummary page 1…cation of Predicate or Legally Marketed Device The OmniSonics Endoscopes are substantially equivalent to several legally marketed devices including: Galileo Endoscopes-K962116 Galileo Disposable Endoscopes K981928 Imagyn Laparascope K944079 Saratoga Medical K943593 Clarus Murphy Scope K962255 SLARMIA… | 1996 |
| * | K981928 | Galileo Disposable EndoscopesSummary page 1…Device The OmniSonics Endoscopes are substantially equivalent to several legally marketed devices including: Galileo Endoscopes-K962116 Galileo Disposable Endoscopes K981928 Imagyn Laparascope K944079 Saratoga Medical K943593 Clarus Murphy Scope K962255 SLARMIANR: OmniSonics Mcdical… | 1998 |
| * | K944079 | Imagyn Microlap (TM) LaparoscopeSummary page 1…oscopes are substantially equivalent to several legally marketed devices including: Galileo Endoscopes-K962116 Galileo Disposable Endoscopes K981928 Imagyn Laparascope K944079 Saratoga Medical K943593 Clarus Murphy Scope K962255 SLARMIANR: OmniSonics Mcdical Technologics "04/20/99 Omni… | 1995 |
| * | K943593 | Saratoga Modular Miniature Endoscope SystemSummary page 1…equivalent to several legally marketed devices including: Galileo Endoscopes-K962116 Galileo Disposable Endoscopes K981928 Imagyn Laparascope K944079 Saratoga Medical K943593 Clarus Murphy Scope K962255 SLARMIANR: OmniSonics Mcdical Technologics "04/20/99 OmniSonics Fiberoptic Endoscop… | 1995 |
| * | K962255 | Clarus Murphypen Endoscope (2127-XXX)Summary page 1…marketed devices including: Galileo Endoscopes-K962116 Galileo Disposable Endoscopes K981928 Imagyn Laparascope K944079 Saratoga Medical K943593 Clarus Murphy Scope K962255 SLARMIANR: OmniSonics Mcdical Technologics "04/20/99 OmniSonics Fiberoptic Endoscope and Coupler Premarket Notif… | 1996 |
What descends from it? (2)
2 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 8 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K080780 (Epitek, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K962116.
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 | — |
What is it indicated for?
The OmniSonics Endoscopes are intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications:
Ureteroscopy
Bronshoscopy
Thoracoscopy
NasopharyngoscopySinuscopy
General laparoscopy
Urology
Gynecological
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/K991377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991377
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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