510(k) · Cleared
ClearedSpider Flexible Blunt Dissector and Band Passer
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 Apr 16, 2012 as substantially equivalent to K100109 (Surgical Innovations Plc, 2010) and 1 other predicate after a 67-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Apr 16, 2012
- Review
- 67 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K932648 (1993). 16 ancestors in all, the oldest K903206 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 6 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 5 generations backK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
- 4 generations backK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- 3 generations backK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- 2 generations backK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- 1 generation backK100109 Logiflex Laparoscopic Band Positioning DeviceSurgical Innovations Plc · 2010
- This deviceK120403 Spider Flexible Blunt Dissector and Band PasserTransenterix, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −6 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −5 | K970826 | Selecta-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1997 | — |
| −4 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| −3 | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| −2 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| −1 | K100109 | Logiflex Laparoscopic Band Positioning Device | Surgical Innovations Plc | 2010 | — |
| 0 (this device) | K120403 | Spider Flexible Blunt Dissector and Band Passer | Transenterix, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K100109 | Logiflex Laparoscopic Band Positioning DeviceSummary page 1…Class 1121 CFR 876.1500 Product Code: GCJ 3. Predicate Devices: Class: 510(k) Number: Device Name/Description: 11 K100109 Logiflex Laparoscopic Band Positioning Device INone Realize Blunt Dissector (previously… | 2010 |
| * | K091697 | Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015Summary page 1…ne Realize Blunt Dissector (previously known as the Obtech Medical Goldfinger Blunt Dissector) 11 K091 697 SPIDER.Flexible Grasper 4. Description: The SPIDER® Flexible Blunt Dissector and Band Passer device is a surgical inst… | 2009 |
| * | — | Realize Blunt Dissector (previously known as the Obtech Medical Goldfinger Blunt… 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 16 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120403: Spider Flexible Blunt Dissector and Band Passer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120403
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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