510(k) · Cleared
ClearedPercuvance 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 Oct 12, 2018 as substantially equivalent to K153063 (Teleflexmedical, Inc., 2016) and 1 other predicate after a 93-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Oct 12, 2018
- Review
- 93 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K912544 (1991). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 5 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 4 generations backK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- 3 generations backK123102 Sovereign MiniAesculap, Inc. · 2013
- 2 generations backK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · Recalled
- 1 generation backK153063 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · Recalled
- This deviceK181852 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −5 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −4 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| −3 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| −2 | K143299 | Percuvance (R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015 | 2 |
| −1 | K153063 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2016 | 9 |
| 0 (this device) | K181852 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K153063 | Percuvance Percutaneous Surgical SystemSummary page 7…Manufacturer 510(k) No. Date Cleared Percuvance™ Percutaneous Teleflex Medical, Inc. K153063 April 8th, 2016 Surgical System Additionally, the technology of Teleflex Medical’s Percuvance™ Clip App… | 2016 |
| * | K133202 | Hem-O-Lok Ligating ClipSummary page 7…flex Medical’s Percuvance™ Clip Applier Tool Tip is substantially equivalent to that of the M/L Hem-o-lok® manual, endoscopic clip appliers cleared in 510(k) K133202. Like the M/L Hem-o-lok® manual, endoscopic clip appliers, the Percuvance™ Clip Applier Tool Tip is compatible with Telefle… | 2013 |
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 27 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 23 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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/K181852 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181852: 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/K181852
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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