510(k) · Cleared
Recalled · 2011Spider Standard and Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transenterix, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 15, 2011 as substantially equivalent to K090902 (Transenterix, Inc., 2009) after a 167-day review. Its family tree reaches back 6 generations to 1994. It has been recalled once.
- Decided
- Mar 15, 2011
- Review
- 167 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K940232 (1994). 25 ancestors in all, the oldest K883018 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 5 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 4 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 3 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 2 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 1 generation backK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
- This deviceK102839 Spider Standard and AdvancedTransenterix, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −5 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −4 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −3 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −2 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −1 | K090902 | Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002… | Transenterix, Inc. | 2009 | 1 |
| 0 (this device) | K102839 | Spider Standard and Advanced | Transenterix, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K090902 | Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Summary page 1…635 Davis Drive Suite 300 Phone: (919) 765-8400 Fax: (919) 765-8459 Predicate Device(s): TransEnterix, Inc. K090902 SPIDERTM Standard and Advanced Device Description: The SPIDER is a pre-sterilized, single use, disposable, l… | 2009 |
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 |
|---|---|---|---|---|
| Feb 25, 2011 | Not classified | Z-1910-2011 | Other | Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 25 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090902.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 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 TM (Single Port Instrument Delivery Extended Reach) devices are intended to establish a path of entry for laparoscopic instruments for minimally invasive abdominal surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102839: Spider Standard and Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102839
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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