510(k) · Cleared

Recalled · Class II · 2013

Navix Access Device

K093279510(k) TraditionalCleared Apr 7, 2010169-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Xlumena · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 7, 2010 as substantially equivalent to K082114 (Apollo Endosurgery, Inc., 2008) and 1 other predicate after a 169-day review. Its family tree reaches back 3 generations to 1997. It has been recalled once.

Decided: Apr 7, 2010
Review: 169 days
Class: Class II
Product code: GCJ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 3 generations to K970053 (1997). 11 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK970053 UltratomerxBoston Scientific Corp · 1997
2 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
1 generation backK022595 Wilson-Cook CystotomeWilson-Cook Medical, Inc. · 2002
This deviceK093279 Navix Access DeviceXlumena · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K970053	Ultratomerx	Boston Scientific Corp	1997	—
−2	K013153	Autotome RX Model # 4515, 4516	Boston Scientific Corp	2001	32
−1	K022595	Wilson-Cook Cystotome	Wilson-Cook Medical, Inc.	2002	—
0 (this device)	K093279	Navix Access Device	Xlumena	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
2000	2	0
2002	1	0
2008	2	0

FIG. 1 — Lineage of K093279, 1997–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K082114	Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 Summary page 1 …Predicate Devices: The NAVIX Access Device is substa ntially equivalent to the following currently marketed predicate devices: (1) Electrocautery Dilation Balloon - K082114 Approved December 19, 2008 Apollo Endosurgery, Inc. Product Code: KNS Regulation: Sec.876.4300 Endoscopic…	Apollo Endosurgery, Inc.	2008	—
*	K022595	Wilson-Cook Cystotome Summary page 1 …2008 Apollo Endosurgery, Inc. Product Code: KNS Regulation: Sec.876.4300 Endoscopic electrosurgical unit and accessories (2) Wilson-Cook Cystotome - K022595 Approved October 17, 2002 Wilson-Cook Medical Inc. Product Code: KNS Regulation: Sec.876.4300 Endoscopic…	Wilson-Cook Medical, Inc.	2002	—

Also cleared against K082114: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 17, 2013	Class II	Z-2167-2013	Process design	A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
1 of the 11 ancestors has a recall of any class.
1 other device also cites its predicate K082114.

How does its category compare?

All GCJ devices

GCJ 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

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)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	—

https://510kreport.com/device/K093279 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093279: Navix Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093279

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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