510(k) · Cleared
ClearedMiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Feb 12, 2018 as substantially equivalent to K070686 (Mini Lap Technologies, Inc., 2007) and 3 other predicates after a 151-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Feb 12, 2018
- Review
- 151 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K945975 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 4 generations backK971565 Bicoag Coagulating ForcepsEverest Medical Corp. · 1998
- 3 generations backK012279 Patton TripolPatton Medical Corp. · 2002
- 2 generations backK023813 Bipolar ForcepsRichard Wolf Medical Instruments Corp. · 2003
- 1 generation backK113597 Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012
- This deviceK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −4 | K971565 | Bicoag Coagulating Forceps | Everest Medical Corp. | 1998 | — |
| −3 | K012279 | Patton Tripol | Patton Medical Corp. | 2002 | — |
| −2 | K023813 | Bipolar Forceps | Richard Wolf Medical Instruments Corp. | 2003 | — |
| −1 | K113597 | Mini-Lap Bipolar Electrocautery Devices | Minilap Technologies | 2012 | — |
| 0 (this device) | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2007 | 2 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K070686 | Mini Lap InstrumentsSummary page 11…edicate devices: Predicate Device Manufacturer 510(k) No. Date Cleared MINI LAP Instruments Teleflex K070686 April 05, 2007 MINI LAP Pediatric Instruments with Medusa Mini-Lap Technologies K070352 Ap… | 2007 |
| * | K070352 | Mini Lap Pediatric Instruments with Medusa Clamping SystemSummary page 11…nstruments Teleflex K070686 April 05, 2007 MINI LAP Pediatric Instruments with Medusa Mini-Lap Technologies K070352 April 05, 2007 Clamping System The proposed MiniLap ThumbGrip MiniPolar Instruments are substantially equivalent… | 2007 |
| * | K083754 | Mini Lap Electrocautery InstrumentsSummary page 11…) No. Date Cleared MINI LAP Electrocautery November 30, Teleflex K083754 Instruments 2009 MINI LAP Pediatric Instruments wi… | 2009 |
| * | K113597 | Mini-Lap Bipolar Electrocautery DevicesSummary page 8…tol grip handle that allows single handed device operation to control the jaws. While these graspers are currently only cleared for electrosurgical configurations (K113597), the intent of this 510(k) is to support non-electrosurgical configurations of the MiniGrip Graspers as well. ThumbGrip I… | 2012 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 5 other devices also cite its predicate K070686.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
MiniLap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery. The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery. The MiniLap System with MiniGrip Handles grasping…
Read the full statement (193 words)
MiniLap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery.
The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery.
The MiniLap System with MiniGrip Handles grasping instruments have applications in a variety of general, thoracic, gynecologic, urologic, laparoscopic and endoscopic procedures for manipulation of tissue, as well as items such as hernia mesh, during pediatric and adult surgery.
Bipolar Grasper instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic, and endoscopic procedures for manipulation and coagulation of tissue and for manipulation of items such as hernia mesh during pediatric and adult surgery.
The male bipolar connection is located at the back of the handle and may be utilized for bipolar applications when attached to standard two plug bipolar cables and their generators (a male connection is provided as an integral part of the instrument).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172775: MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172775
Report an extraction error
Are you the manufacturer?
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