510(k) · Cleared
ClearedSpider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical Instruments, Flexible Monopolar
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 Oct 25, 2012 as substantially equivalent to K091697 (Transenterix, Inc., 2009) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Oct 25, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K904578 (1990). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK904578 Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc · 1990
- 1 generation backK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
- This deviceK122299 Spider Surgical Instruments, Flexible Monopolar Grasper Wavy…Transenterix, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK124029 Microline Flexible Ligating ShearsMicroline Surgical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K124029Microline Flexible Ligating ShearsMicroline Surgical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904578 | Modification Auto Suture (R) Endoscopic Clamp | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −1 | K091869 | Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears | Covidien Lp, Formerly Registered AS United States | 2009 | — |
| 0 (this device) | K122299 | Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider… | Transenterix, Inc. | 2012 | — |
| +1 | K124029 | Microline Flexible Ligating Shears | Microline Surgical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K091697 | Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015Summary page 1…Product Code: GEl 3. Predicate Devices: Class Manufacturer 510(k) Number Device Name/Description 11 TransEnterix K091697 SPIDER® Flexible Instruments: Maryland K102646 Dissector, Graspers (Blunt nose), Shear… | 2009 |
| * | K102646 | Spider Flex Monopolar HookSummary page 1…er 510(k) Number Device Name/Description 11 TransEnterix K091697 SPIDER® Flexible Instruments: Maryland K102646 Dissector, Graspers (Blunt nose), Shears 11 Covidien K091869 SILS' m Clincher, Graspers, Dissector… | 2010 |
| * | K091869 | Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsSummary page 1…K091697 SPIDER® Flexible Instruments: Maryland K102646 Dissector, Graspers (Blunt nose), Shears 11 Covidien K091869 SILS' m Clincher, Graspers, Dissector, Shears 4. Description: The S… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124029 | Microline Flexible Ligating Shears | 2013 | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K124029 (Microline Surgical, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K091697.
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® 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 as stated in the FDA summary.
https://510kreport.com/device/K122299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122299: Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical Instruments, Flexible Monopolar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122299
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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