510(k) · Cleared
ClearedNavient Image Guided Navigation System (ENT) (955-NC-NC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Claronav · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Jun 20, 2025 as substantially equivalent to K163439 (Claronav, Inc., 2017) after a 266-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jun 20, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983831 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 2 generations backK122096 Karl Storz Navigationpanel Unit (Npu) SystemKARL STORZ Endoscopy-America, Inc. · 2012
- 1 generation backK163439 NaviENTClaronav, Inc. · 2017
- This deviceK243053 Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −2 | K122096 | Karl Storz Navigationpanel Unit (Npu) System | KARL STORZ Endoscopy-America, Inc. | 2012 | — |
| −1 | K163439 | NaviENT | Claronav, Inc. | 2017 | — |
| 0 (this device) | K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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 PGW? 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 PGW device
- #1 K261540 Cube 4D Navigation System, VirtuEye Proscore 12.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K163439 | NaviENTSummary page 5…882.4560 Regulation Name Stereotaxic instrument Classification Panel Ear Nose & Throat Predicate Devices Primary predicate: NaviENT System (K163439) Indications for Use Page 1 of 12 === Page… | 2017 |
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 26 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All PGW devicesPGW Ear, Nose, And Throat Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGW
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGW
220in 2025
MAUDE reports naming product code PGW, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 116 | 0 | 7 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 9 | 115 | 0 | 33 |
| 2017 | 4 | 125 | 0 | 42 |
| 2018 | 2 | — | 0 | 96 |
| 2019 | 1 | — | 3 | 247 |
| 2020 | 8 | 100 | 0 | 161 |
| 2021 | 1 | — | 1 | 190 |
| 2022 | 2 | — | 0 | 166 |
| 2023 | 2 | — | 1 | 200 |
| 2024 | 0 | — | 0 | 274 |
| 2025 | 1 | — | 1 | 220 |
| 2026 | 3 | 65 | 0 | — |
What is it indicated for?
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures. The Navient system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT, MR-based anatomy model.
Indications:
Example procedures include but are not limited to:
ENT Procedures:
• Transsphenoidal procedures
• Maxillary antrostomies
• Ethmoidectomies
• sphenoidotomies
• Sphenoid explorations
• Turbinate resections
• Frontal sinusotomies
• Intranasal procedures
• Intranasal tumor resections
• All ENT related skull base surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243053 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243053: Navient Image Guided Navigation System (ENT) (955-NC-NC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243053
Report an extraction error
Are you the manufacturer?
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