510(k) · Cleared

Cleared

Ksea Sialoendoscopes and Accessories

K012527510(k) TraditionalCleared Nov 1, 200187-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

KARL STORZ Endoscopy-America, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 1, 2001 after an 87-day review. The FDA summary names no predicate by number. 13 later devices descend from it.

Decided: Nov 1, 2001
Review: 87 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 0

13 later devices descend from it, 6 citing it directly.

This deviceK012527 Ksea Sialoendoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2001
Descendant · cites it directly · 6 of its ownK070752 Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc. · 2007
Descendant · 2 generations on · 5 of its ownK082569 Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008
Descendant · 3 generations on · 3 of its ownK162916 3NT endoscopy system3nt Medical, Ltd. · 2017
Descendant · cites it directly · 2 of its ownK051073 Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
Descendant · cites it directly · 1 of its ownK072749 Sialo Balloon Dilatation CatheterSialo Technology, Ltd. · 2008

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2006high 2 (2008) · low 0 (2013)2026

Most influential descendants

Showing 5 of 13 · See all

K070752Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc. · 2007 · cites it directly6descendants
K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008 · 2 generations on5descendants
K1629163NT endoscopy system3nt Medical, Ltd. · 2017 · 3 generations on3descendants
K051073Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006 · cites it directly2descendants
K072749Sialo Balloon Dilatation CatheterSialo Technology, Ltd. · 2008 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012527	Ksea Sialoendoscopes and Accessories	KARL STORZ Endoscopy-America, Inc.	2001	—
+1	K070752	Ksea Miniature Endoscope, Model 11565	KARL STORZ Endoscopy-America, Inc.	2007	—
+2	K082569	Entellus Medical Flexible Endoscope and Eyepiece	Entellus Medical, Inc.	2008	—
+3	K162916	3NT endoscopy system	3nt Medical, Ltd.	2017	—
+1	K051073	Midiview Series of Microendoscopes	Millennium Devices, Inc.	2006	—
+1	K072749	Sialo Balloon Dilatation Catheter	Sialo Technology, Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2014	1	0
2017	1	0
2020	1	0
2021	1	0
2022	1	0

FIG. 1 — Lineage of K012527, 2001–2022Source: 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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (13)

See all 13

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070752	Ksea Miniature Endoscope, Model 11565	KARL STORZ Endoscopy-America, Inc.	2007	6
K051073	Midiview Series of Microendoscopes	Millennium Devices, Inc.	2006	2
K072749	Sialo Balloon Dilatation Catheter	Sialo Technology, Ltd.	2008	1
K120468	Ncircle (R) Nitinol Tipless Stone Extractor Ngage (R) Nitinol Stone Extractor	Cook Incorporated	2012	0
K093785	Modular Endoscope	Sialo Technology, Ltd.	2010	0
K082735	Stone Grasping Basket, Model PD-T1 2115	Sialo Technology, Ltd.	2009	0

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?

Of its descendants, K070752 (KARL STORZ Endoscopy-America, Inc., 2007) has gone furthest, with 6 descendants of its own.

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?

The KSEA Sialoendoscopes and Accessories are for use by qualified surgeons in the diagnosis and treatment of salivary gland diseases. The Sialoendoscope is used to visualize the surgical site in salivary gland diagnostic and therapeutic procedures. The sheath is to protect the telescope. The obturator allows the surgeon to gain access to the surgical site without damaging other tissue layers. The grasping forceps are used to hold, grasp and remove stone fragments. The stone basket is used to entrap and remove stone fragments in salivary gland endoscopic therapeutic procedures.

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/K012527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012527: Ksea Sialoendoscopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012527

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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