510(k) · Cleared
ClearedAnchorage Scope, Model 000003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epitek, Inc. · FBO Cystourethroscope
Cleared on Jul 30, 2008 as substantially equivalent to K991377 (Omnisonics Medical Technologies, 1999) after a 133-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jul 30, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- FBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912089 (1991). 8 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 deviceK080780 Anchorage Scope, Model 000003Epitek, Inc. · 2008
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) | K080780 | Anchorage Scope, Model 000003 | Epitek, Inc. | 2008 | — |
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 |
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 FBO? 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 FBO device
- #1 K244001 KARL STORZ Cysto-Urethro-Fiberscope…score 9.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 1…E: The subject device is substantially equivalent (i.e., has the same intended use and technological characteristics) to the Flexible Fiber Optic Endoscope and Coupler (K991377) from OmniSonics Medical Technologies. DEVICE DESCRIPTION: The AnchorageTM Scope is a flexible fiber optic endoscope provided a… | 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 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K991377.
How does its category compare?
All FBO devicesFBO Cystourethroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FBO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBO
Too few FBO 510(k)s in any year since 2007 to give a median.
Recalls per year · FBO
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBO
26in 2025
MAUDE reports naming product code FBO, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 5 | 33 |
| 2023 | 0 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 30 |
| 2025 | 1 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AnchorageTM Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is 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 Anchorage Scope is indicated for the following applications:
Ureteroscopy
Bronchoscopy
Thoracoscopy
Nasopharyngoscopy/Sinuscopy
General laparascopy
Urology
Gynecology
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080780: Anchorage Scope, Model 000003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080780
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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