510(k) · Cleared
Recalled · Class II · 2016Percuvance (R) Percutaneous Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jan 21, 2015 as substantially equivalent to K123102 (Aesculap, Inc., 2013) after a 65-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 21, 2015
- Review
- 65 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912544 (1991). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 3 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 2 generations backK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- 1 generation backK123102 Sovereign MiniAesculap, Inc. · 2013
- This deviceK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK153063 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK181852 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −3 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −2 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| −1 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| 0 (this device) | K143299 | Percuvance (R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015 | — |
| +1 | K153063 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2016 | 9 |
| +2 | K181852 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K123102 | Sovereign MiniSummary page 5…System: Predicate Device Manufacturer 510(k) No. Date Cleared Sovereign® Mini Aesculap, Inc. K123102 01/03/2013 I. Comparison to Predicate Devices Teleflex Medical’s proposed Percuvance® Percutaneous Surgical System… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153063 | Percuvance Percutaneous Surgical System | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2016 | Class II | Z-0058-2017 | Process control | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers. |
| Sep 9, 2016 | Class II | Z-0059-2017 | Process control | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K153063 (Teleflexmedical, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K123102.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143299: Percuvance (R) Percutaneous Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143299
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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