510(k) Report

510(k) · Cleared

Cleared

Ensizor Endoscopic Scissors

K150939510(k) TraditionalCleared Jun 8, 201562-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Slater Endoscopy, LLC · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

Cleared on Jun 8, 2015 as substantially equivalent to K141058 (Slater Endoscopy, LLC, 2014) and 1 other predicate after a 62-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.

Decided
Jun 8, 2015
Review
62 days
Class
Class II
Product code
OCZ
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K932648 (1993). 16 ancestors in all, the oldest K903206 (1990). 2 later devices descend from it, 2 citing it directly.

  1. Root · 8 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
  2. 7 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
  3. 6 generations backK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
  4. 5 generations backK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
  5. 4 generations backK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
  6. 3 generations backK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
  7. 2 generations backK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
  8. 1 generation backK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
  9. This deviceK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
  10. Descendant · cites it directly · 0 of its ownK242923 SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip…Envision Endoscopy · 2024
  11. Descendant · cites it directly · 0 of its ownK180134 Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…Envision Endoscopy · 2024 · cites it directly0descendants
  • K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K932648Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc.1993—
−7K962119RE-New Laparoscopic InstrumentsMicroline Pentax, Inc.19962
−6K970826Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc.1997—
−5K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc.1998—
−4K014207Reposable Instrument System, Models MF001-MF083Aesculap, Inc.2002—
−3K063485Logic Laparoscopic ScissorsSurgical Innovations Plc2006—
−2K090583Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc.2009—
−1K141058Ensizor Endoscopic ScissorsSlater Endoscopy, LLC2014—
0 (this device)K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC2015—
+1K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture…Envision Endoscopy2024—
+1K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199310
199420
199710
200110
200410
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202410
FIG. 1 — Lineage of K150939, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.4 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K141058Ensizor Endoscopic Scissors
Summary page 4
…substantial equivalence: The EnsizorTM Endoscopic Scissor is substantially equivalent to the EnsizorTM Endoscopic Scissor (K141058) and the US Endoscopy Suture Cutter Device (K133736). (4) Description of device(s): E…
Slater Endoscopy, LLC2014—
*K133736Endoscopic Suture Cutter
Summary page 4
…rTM Endoscopic Scissor is substantially equivalent to the EnsizorTM Endoscopic Scissor (K141058) and the US Endoscopy Suture Cutter Device (K133736). (4) Description of device(s): Ensizor™ Endoscopic Scissor • Cat # ES-26165…
United States Endoscopy Group, Inc.2014—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…Envision Endoscopy20240
K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC20180

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 22 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 16 ancestors has a recall of any class.
  • Of its descendants, K242923 (Envision Endoscopy, 2024) has gone furthest, with 0 descendants of its own.

How does its category compare?

All OCZ devices

OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · OCZ

1in 2024

2008: 12010: 12011: 12012: 12014: 22015: 12016: 12020: 12024: 12026 (partial year): 1
2007high 2 (2014) · low 0 (2007)2026

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

2022: 17
2007high 17 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCZ

34in 2025

2007: 12008: 22009: 22010: 22012: 62013: 42014: 12015: 2422016: 7592017: 7342018: 2522019: 152020: 212021: 202022: 332023: 252024: 372025: 34
2007high 759 (2016) · low 0 (2011)2025

MAUDE reports naming product code OCZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20081—02
20090—02
20101—02
20111—00
20121—06
20130—04
20142—01
20151—0242
20161—0759
20170—0734
20180—0252
20190—015
20201—021
20210—020
20220—1733
20230—025
20241—037
20250—034
20261—0—

What is it indicated for?

Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and dissect tissue and 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.

Cite this page

510(k) Report. “K150939: Ensizor Endoscopic Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150939

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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