510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015

K091697510(k) TraditionalCleared Sep 28, 2009110-day reviewClass II21 CFR 876.1500Recalls 2

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 Sep 28, 2009 after a 110-day review. The FDA summary names no predicate by number. 49 later devices descend from it. It has been recalled 2 times.

Decided
Sep 28, 2009
Review
110 days
Class
Class II
Product code
GCJ
Recalls
2
Predicates
0

49 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2012: 3 descendants cleared2011: 1 descendant cleared2016: 2 descendants cleared2013: 3 descendants cleared2014: 4 descendants cleared2017: 2 descendants cleared2018: 3 descendants cleared2015: 1 descendant cleared2019: 2 descendants cleared2024: 6 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2021: 3 descendants cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK091697 Spider Surgical Instruments, Models 90004, 90005, 90007, 90009…Transenterix, Inc. · 2009
  2. Descendant · cites it directly · 46 of its ownK102646 Spider Flex Monopolar HookTransenterix, Inc. · 2010
  3. Descendant · cites it directly · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
  4. Descendant · 2 generations on · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
  5. Descendant · 2 generations on · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
  6. Descendant · 2 generations on · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 32013: 32014: 42015: 12016: 22017: 22018: 32019: 22020: 32021: 32022: 12023: 32024: 62025: 82026: 3
2010high 8 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 49 · See all
  • K102646Spider Flex Monopolar HookTransenterix, Inc. · 2010 · cites it directly46descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K091697Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012…Transenterix, Inc.2009—
+1K102646Spider Flex Monopolar HookTransenterix, Inc.2010—
+1K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201112
+2K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc.20123
+2K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.20136
+2K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201230
201330
201440
201510
201620
201720
201830
201920
202030
202130
202210
202330
202460
202580
202630
FIG. 1 — Lineage of K091697, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K102646Spider Flex Monopolar HookTransenterix, Inc.201046
K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201143
K122299Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical…Transenterix, Inc.20121
K160797FMX314 Surgical PlatformFortimedix Surgical B.V.20160
K120403Spider Flexible Blunt Dissector and Band PasserTransenterix, Inc.20120

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 2, 2012Class IIZ-2137-2012Process controlSome clip applier units may be inadequate to achieve clip closure.
Jun 22, 2010Not classifiedZ-2465-2010OtherThe hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laproscopic surgery. Retrieval from the patient may involve extended anesthesia time.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K102646 (Transenterix, Inc., 2010) has gone furthest, with 46 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. 2009, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
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

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

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, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Transenterix, Inc.

15 FDA decisions under this applicant name. See the company

  • K202166Senhance Surgical SystemTransenterix, Inc. · 2021
  • K200049Senhance Surgical SystemTransenterix, Inc. · 2020
  • K192877Senhance Surgical SystemTransenterix, Inc. · 2019
  • K191482Senhance Surgical SystemTransenterix, Inc. · 2019
  • K182421Senhance Ultrasonic SystemTransenterix, Inc. · 2019

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K091697 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091697: Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091697

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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