510(k) · Cleared

Cleared

Endo-Glide

K013701510(k) TraditionalCleared Feb 4, 200288-day reviewClass II21 CFR 876.1500

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

Sonotech, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Feb 4, 2002 as substantially equivalent to K984562 (Sonotech, Inc., 1999) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1978.

Decided: Feb 4, 2002
Review: 88 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K780386 (1978). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK780386 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1978
This deviceK013701 Endo-GlideSonotech, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K780386	K-Y Lubricating Jelly	Johnson & Johnson Professionals, Inc.	1978	—
0 (this device)	K013701	Endo-Glide	Sonotech, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1999	1	0

FIG. 1 — Lineage of K013701, 1978–2002Source: 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? (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	Applicant	Decided	Recalls
*	K984562	Vivosonic Summary page 1 …ement of substantial equivalence Endo-Glide is equivalent in formula to: -A. VivoSonic In Vivo Biocompatible/Biodegradable Sterile Ultrasound Couplant; (Sonotech, Inc.) K984562, clearance received June 8, 1999; MUI; Class Il Endo-Glide is equivalent in use to: A. K-Y Jelly; for transurethral surgical in…	Sonotech, Inc.	1999	—
*	K780386	K-Y Lubricating Jelly Summary page 1 …e received June 8, 1999; MUI; Class Il Endo-Glide is equivalent in use to: A. K-Y Jelly; for transurethral surgical instruments (Johnson & Johnson Professionals, Inc.) K780386, clearance received 04/13/1978; FHX78, Class I B. K-Y Jelly; patient lubricant (Johnson & Johnson Professionals, Inc.) K810310,…	Johnson & Johnson Professionals, Inc.	1978	—
*	K810310	K-Y Lubricating Jelly Summary page 1 …s (Johnson & Johnson Professionals, Inc.) K780386, clearance received 04/13/1978; FHX78, Class I B. K-Y Jelly; patient lubricant (Johnson & Johnson Professionals, Inc.) K810310, clearance received 04/21/1981; KMJ, Class \| C. Surgilube 2% Yy ' ®, Sonotech, Inc. SOTEcH N 774 Marine Dr. Bel…	Johnson & Johnson Professionals, Inc.	1981	—
*	—	Surgilube 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?

None of the 3 ancestors has a recall.

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.

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	—

What is it indicated for?

Lubricate the insertion and passage of imaging devices and surgical instrumentation, such as endoscopes, ultrasound transducers, transesophageal echocardiography (TEE) transducers, catheters and surgical instrumentation.

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/K013701 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013701: Endo-Glide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013701

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026