510(k) · Cleared
ClearedSimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envision Endoscopy · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Dec 20, 2024 as substantially equivalent to K150939 (Slater Endoscopy, LLC, 2015) after an 87-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Dec 20, 2024
- Review
- 87 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K932648 (1993). 17 ancestors in all, the oldest K903206 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 5 generations between
- 3 generations backK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- 2 generations backK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- 1 generation backK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
- This deviceK242923 SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip…Envision Endoscopy · 2024
Show all 9 generations
- Root · 9 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 8 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 7 generations backK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
- 6 generations backK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- 5 generations backK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- 4 generations backK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- 3 generations backK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- 2 generations backK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- 1 generation backK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
- This deviceK242923 SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip…Envision Endoscopy · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −8 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −7 | K970826 | Selecta-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1997 | — |
| −6 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| −5 | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| −4 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| −3 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| −2 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
| −1 | K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2015 | — |
| 0 (this device) | K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture… | Envision Endoscopy | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 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 OCZ? 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 OCZ device
- #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.4 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K150939 | Ensizor Endoscopic ScissorsSummary page 5…es: Proprietary Name: Ensizor Endoscopic Scissors Manufacturer: Slater Endoscopy LLC 510(k) Number: K150939 Common Name: Endoscopic Grasping/Cutting Instrument, Non-powered Classification Name:… | 2015 |
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 31 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K150939.
How does its category compare?
All OCZ devicesOCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OCZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCZ
Too few OCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCZ
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCZ
34in 2025
MAUDE reports naming product code OCZ, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 242 |
| 2016 | 1 | — | 0 | 759 |
| 2017 | 0 | — | 0 | 734 |
| 2018 | 0 | — | 0 | 252 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 17 | 33 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.
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/K242923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242923: SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242923
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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