510(k) · Cleared
Recalled · Class II · 2018Percuvance Percutaneous Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 8, 2016 as substantially equivalent to K143299 (Teleflexmedical, Inc., 2015) and 1 other predicate after a 169-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Apr 8, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 5 generations to K912544 (1991). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 4 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 3 generations backK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- 2 generations backK123102 Sovereign MiniAesculap, Inc. · 2013
- 1 generation backK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · Recalled
- This deviceK153063 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK181852 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181852Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −4 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −3 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| −2 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| −1 | K143299 | Percuvance (R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015 | 2 |
| 0 (this device) | K153063 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2016 | — |
| +1 | 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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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? (2)
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 |
|---|---|---|---|
| * | K143299 | Percuvance (R) Percutaneous Surgical SystemSummary page 5…ngeable with components from other percutaneous systems, including those of the existing Percuvance™ Percutaneous Surgical System, which was cleared under 510(k) K143299. Initial access to the surgical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the pat… | 2015 |
| * | K083754 | Mini Lap Electrocautery InstrumentsSummary page 7…reference Hem-o-lok® Ligating Clip System, respectively. The following are indications for use of the predicate MiniLap® MiniPolar Electrocautery Instruments (K083754): The MiniPolar Instruments are used to cut and cauterize soft tissue. The following are indications for use… | 2009 |
| † | K133202 | Hem-O-Lok Ligating Clip | 2013 |
| † | K040855 | Instrumed Laparoscope and Accessories | 2004 |
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 |
|---|---|---|---|
| K181852 | Percuvance Percutaneous Surgical System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2018 | Class II | Z-0753-2019 | Process control | There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur… |
| Jan 3, 2018 | Class II | Z-0754-2019 | Process control | There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur… |
| Oct 18, 2017 | Class II | Z-0059-2018 | Under Investigation by firm | Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. |
| Jul 19, 2017 | Class II | Z-3222-2017 | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. |
| Jul 19, 2017 | Class II | Z-3220-2017 | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. |
| Jul 19, 2017 | Class II | Z-3223-2017 | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. |
| Jul 19, 2017 | Class II | Z-3224-2017 | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. |
| Jul 19, 2017 | Class II | Z-3221-2017 | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. |
| Jul 19, 2017 | Class II | Z-3219-2017 | Device Design | For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K181852 (Teleflexmedical, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153063 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153063: Percuvance Percutaneous Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153063
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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