510(k) · Cleared

Cleared

Spider Flex Monopolar Hook

K102646510(k) SpecialCleared Nov 3, 201050-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

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

Cleared on Nov 3, 2010 as substantially equivalent to K091697 (Transenterix, Inc., 2009) after a 50-day review. Its family tree reaches back 1 generation to 2009. 46 later devices descend from it.

Decided: Nov 3, 2010
Review: 50 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K091697 (2009). 46 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK091697 Spider Surgical Instruments, Models 90004, 90005, 90007, 90009…Transenterix, Inc. · 2009 · Recalled
This deviceK102646 Spider Flex Monopolar HookTransenterix, Inc. · 2010
Descendant · cites it directly · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
Descendant · 2 generations on · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
Descendant · 2 generations on · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
Descendant · 2 generations on · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
Descendant · 3 generations on · 21 of its ownK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2011high 8 (2025) · low 1 (2011)2026

Most influential descendants

Showing 5 of 46 · See all

K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · cites it directly43descendants
K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc. · 2012 · 2 generations on42descendants
K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · 2 generations on39descendants
K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014 · 2 generations on22descendants
K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · 3 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K091697	Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012…	Transenterix, Inc.	2009	2
0 (this device)	K102646	Spider Flex Monopolar Hook	Transenterix, Inc.	2010	—
+1	K112208	Intutive Surgical DA Vinci Single Site Instruments and Accessories	Intuitive Surgical, Inc.	2011	12
+2	K120215	Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…	Intuitive Surgical, Inc.	2012	3
+2	K122532	DA Vinci Single-Site Instruments and Accessories	Intuitive Surgical, Inc.	2013	6
+2	K131962	DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories	Intuitive Surgical, Inc.	2014	—
+3	K173906	da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories	Intuitive Surgical, Inc.	2018	9

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	2	0
2013	3	0
2014	4	0
2015	1	0
2016	1	0
2017	2	0
2018	3	0
2019	2	0
2020	3	0
2021	3	0
2022	1	0
2023	3	0
2024	6	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K102646, 2009–2026Source: 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.

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#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
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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	Applicant	Decided	Recalls
*	K091697	Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 Summary page 1 …e: Endoscope and accessories Classification: Class 1121 CFR 876.1500 Product Code:GJ Predicate Device(s): TransEnterix, Inc. K091 697 SPIDERTM Surgical Instruments, Flex Monopolar Hook Device Description: The Flex Monopolar Hook is a pre-sterilized, single use,…	Transenterix, Inc.	2009	2

Also cleared against K091697: 4 other devices →

What descends from it? (46)

See all 46

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

Number	Device	Applicant	Decided	Descendants
K112208	Intutive Surgical DA Vinci Single Site Instruments and Accessories	Intuitive Surgical, Inc.	2011	43
K122299	Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical…	Transenterix, Inc.	2012	1

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?

Its one ancestor has a recall.
Of its descendants, K112208 (Intuitive Surgical, Inc., 2011) has gone furthest, with 43 descendants of its own.
4 other devices also cite its predicate K091697.

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	—

What is it indicated for?

The SPIDER Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, retracting, cuffing, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102646: Spider Flex Monopolar Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102646

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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