510(k) · Cleared
ClearedModular Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sialo Technology, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 18, 2010 as substantially equivalent to K012527 (KARL STORZ Endoscopy-America, Inc., 2001) and 3 other predicates after a 252-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Aug 18, 2010
- Review
- 252 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K926166 (1993). 18 ancestors in all, the oldest K910732 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK926166 Coast Video Endoscopic Imaging SystemOptik · 1993
- 3 generations backK983538 Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic…Solos Endoscopy, Inc. · 1998
- 2 generations backK983527 Microendoscope, Miniaturized Biopsy ScopeDofi Technologies, Inc. · 1999
- 1 generation backK051073 Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
- This deviceK093785 Modular EndoscopeSialo Technology, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926166 | Coast Video Endoscopic Imaging System | Optik | 1993 | — |
| −3 | K983538 | Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing… | Solos Endoscopy, Inc. | 1998 | — |
| −2 | K983527 | Microendoscope, Miniaturized Biopsy Scope | Dofi Technologies, Inc. | 1999 | — |
| −1 | K051073 | Midiview Series of Microendoscopes | Millennium Devices, Inc. | 2006 | — |
| 0 (this device) | K093785 | Modular Endoscope | Sialo Technology, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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? (4)
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 |
|---|---|---|---|
| * | K012527 | Ksea Sialoendoscopes and AccessoriesSummary page 1…n: Class II medical Device Predicate Device: The Modular Endoscope is comparable to the following predicate devices: * KSEA Sialoendoscope and accessories (K012527) manufactured by Karl Storz Endoscopy. * Midiview'series of microendoscopes (K(051073) manufactured by Millennium… | 2001 |
| * | K051073 | Midiview Series of MicroendoscopesSummary page 1…following predicate devices: * KSEA Sialoendoscope and accessories (K012527) manufactured by Karl Storz Endoscopy. * Midiview'series of microendoscopes (K(051073) manufactured by Millennium Devices Inc. • SpyGlasSTM Direct Visualization Probe (K050403) manufactured by Boston… | 2006 |
| * | K050403 | Spyglass Direct Visulation ProbeSummary page 1…arl Storz Endoscopy. * Midiview'series of microendoscopes (K(051073) manufactured by Millennium Devices Inc. • SpyGlasSTM Direct Visualization Probe (K050403) manufactured by Boston Scientific Corporation. * OraScope (K991101) manufactured by FiberDent Corp.… | 2005 |
| * | K991011 | Orascope Our reading of the summary gave K991101, FDA’s number for Coag-a-Mate Max (Organon Teknika Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “OraScope”. | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 18 ancestors has a recall.
- 5 other devices also cite its predicate K012527.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Modular Endoscope is intended for use for visualization and to magnify and
illuminate body cavities, hollow organs and canals in ENT procedures. The Modular
Endoscope is intended for use for visualization and to magnify and illuminate dental
surfaces. The Modular Endoscope is intended for using additional accessories to perform
various diagnostic and therapeutic procedures in ENT Surgery, including but not limited
to, salivary gland diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093785: Modular Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093785
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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