510(k) · Cleared
ClearedMins Needlescopic Resposable Device System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minilap Technologies · OCW Endoscopic Tissue Approximation Device
Cleared on Dec 4, 2013 as substantially equivalent to K070686 (Mini Lap Technologies, Inc., 2007) and 2 other predicates after a 139-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Dec 4, 2013
- Review
- 139 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K945975 (1994). 32 ancestors in all, the oldest K912544 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 6 generations backK972558 Bipolar ScissorsEnable Medical Corp. · 1997
- 5 generations backK981219 Oscar Bipolar Scissors and Oscar Bipolar Reusable CartridgesEnable Medical Corp. · 1998
- 4 generations backK992996 Enable Endoscopic Bipolar ScissorsEnable Medical Corp. · 1999
- 3 generations backK001330 Sovereign Bipolar InstrumentsAesculap, Inc. · 2000
- 2 generations backK030890 SwitchbladeSnowden Pencer, Inc. · 2003
- 1 generation backK113407 Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsCarefusion 2200, Inc. · 2012
- This deviceK132232 Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −6 | K972558 | Bipolar Scissors | Enable Medical Corp. | 1997 | — |
| −5 | K981219 | Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges | Enable Medical Corp. | 1998 | — |
| −4 | K992996 | Enable Endoscopic Bipolar Scissors | Enable Medical Corp. | 1999 | — |
| −3 | K001330 | Sovereign Bipolar Instruments | Aesculap, Inc. | 2000 | — |
| −2 | K030890 | Switchblade | Snowden Pencer, Inc. | 2003 | — |
| −1 | K113407 | Snowden Pencer Laparoscopic Ergonomic Reposable Scissors | Carefusion 2200, Inc. | 2012 | — |
| 0 (this device) | K132232 | Mins Needlescopic Resposable Device System | Minilap Technologies | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K070686 | Mini Lap InstrumentsSummary page 2…that have been used in medical devices for many years. The patient contact materials are biocompatible and are identical to the predicate Minilap device (K070686) which passed testing to ISO 10993. Cleaning, Disinfection, Sterilization and Pyrogenicity The MiNS Needlescop… | 2007 |
| * | K113407 | Snowden Pencer Laparoscopic Ergonomic Reposable ScissorsSummary page 3…lowing devices have been identified as predicate devices: " Mini Lap Instruments - K070686 " Snowden-Pencer-Resposable Laparoscopic Scissors- KI 113407 " Aesculap Needlescopic Instrument System- K982623 Predicate Device Comparison The Mini Lap MiNS Needlescop… | 2012 |
| * | K982623 | Aesculap Needlescopic Instrument SystemSummary page 3…" Mini Lap Instruments - K070686 " Snowden-Pencer-Resposable Laparoscopic Scissors- KI 113407 " Aesculap Needlescopic Instrument System- K982623 Predicate Device Comparison The Mini Lap MiNS Needlescopic Resposable device systems are, in principal and function, id… | 1998 |
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 19 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 32 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. 2013, 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?
The MiNS grasping instruments are a family of minimally invasive devices with the means to penetrate soft issue 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132232: Mins Needlescopic Resposable Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132232
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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