510(k) Report

510(k) · Cleared

Cleared

Endoscopic Suture Cutter

K133736510(k) TraditionalCleared Jan 7, 201429-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

United States Endoscopy Group, Inc. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

Cleared on Jan 7, 2014 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided
Jan 7, 2014
Review
29 days
Class
Class II
Product code
OCZ
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2010201520202025
  1. This deviceK133736 Endoscopic Suture CutterUnited States Endoscopy Group, Inc. · 2014
  2. Descendant · cites it directly · 2 of its ownK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
  3. Descendant · 2 generations on · 0 of its ownK242923 SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip…Envision Endoscopy · 2024
  4. Descendant · 2 generations on · 0 of its ownK180134 Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015 · cites it directly2descendants
  • K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…Envision Endoscopy · 2024 · 2 generations on0descendants
  • K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K133736Endoscopic Suture CutterUnited States Endoscopy Group, Inc.2014—
+1K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC2015—
+2K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture…Envision Endoscopy2024—
+2K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201810
202410
FIG. 1 — Lineage of K133736, 2014–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC20152

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?

  • Of its descendants, K150939 (Slater Endoscopy, LLC, 2015) has gone furthest, with 2 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. 2014, 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?

The US Endoscopy Endoscopic Suture Cutter Device is intended to be used in conjunction with an endoscope to grasp and cut suture in the GI tract.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K133736: Endoscopic Suture Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133736

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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