510(k) · Cleared
ClearedOmnisonic Endoscopic Deflector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnisonics Medical Technologies · GCM Endoscope, Rigid
Cleared on Dec 6, 1999 as substantially equivalent to K991377 (Omnisonics Medical Technologies, 1999) and 2 other predicates after a 55-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Dec 6, 1999
- Review
- 55 days
- Class
- Class II
- Product code
- GCM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K912089 (1991). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK912089 Modified Series 2100 EndoscopesMedical Laser, Inc. · 1991
- 2 generations backK962255 Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc. · 1996
- 1 generation backK991377 Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999
- This deviceK993445 Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912089 | Modified Series 2100 Endoscopes | Medical Laser, Inc. | 1991 | — |
| −2 | K962255 | Clarus Murphypen Endoscope (2127-XXX) | Clarus Medical Systems, Inc. | 1996 | — |
| −1 | K991377 | Omnisonics Flexible Fiber Optic Endoscope and Coupler | Omnisonics Medical Technologies | 1999 | — |
| 0 (this device) | K993445 | Omnisonic Endoscopic Deflector | Omnisonics Medical Technologies | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 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 GCM? 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 GCM device
- #1 K203226 Telescope 0 O 10MM WL 305MM / Telescope 30 O…score 7.3 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K991377 | Omnisonics Flexible Fiber Optic Endoscope and CouplerSummary page 4…ral legally marketed devices in intended use, design and technological characteristics. Those devices to which it is substantially equivalent are: Omnisonics Endoscopes (K991377), Karl Storz Hystero-Fiberscope (K990411), Karl Storz Laser Application Instrument (K# unknown), and the Naviport Deflectable Tip… | 1999 |
| * | K990411 | MVM 7.5 French Flexible HysteroscopeSummary page 4…use, design and technological characteristics. Those devices to which it is substantially equivalent are: Omnisonics Endoscopes (K991377), Karl Storz Hystero-Fiberscope (K990411), Karl Storz Laser Application Instrument (K# unknown), and the Naviport Deflectable Tip Guiding Catheter (K974683). 4. Device D… | 1999 |
| * | K974683 | Naviport Deflectable Tip Guiding CatheterSummary page 4…s Endoscopes (K991377), Karl Storz Hystero-Fiberscope (K990411), Karl Storz Laser Application Instrument (K# unknown), and the Naviport Deflectable Tip Guiding Catheter (K974683). 4. Device Description Principle of Operation The OmniSonics Endoscopic Deflector assists in the delivery of small diameter f… | 1999 |
| * | — | Karl Storz Laser Application Instrument Named without a submission number |
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 8 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K991377.
How does its category compare?
All GCM devicesGCM Endoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCM
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · GCM
Too few GCM 510(k)s in any year since 2007 to give a median.
Recalls per year · GCM
No recall names GCM since 2007.
Adverse event reports per year · GCM
607in 2025
MAUDE reports naming product code GCM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 449 |
| 2025 | 0 | — | 0 | 607 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of small diameter malleable instruments, catheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals. The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside…
Read the full statement (108 words)
The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of small diameter malleable instruments, catheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals.
The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications:
Ureteroscopy
Thoracoscopy
Nasopharyngoscopy Sinuscopy
General laparoscopy
Urology
Gynecology
Bronchoscopy
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/K993445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993445: Omnisonic Endoscopic Deflector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993445
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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