510(k) Report

510(k) · Cleared

Cleared

Single Use Grasping Forceps

K191900510(k) TraditionalCleared Mar 27, 2020255-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

Zhejiang Chuangxiang Medical Technology Co., Ltd. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

Cleared on Mar 27, 2020 as substantially equivalent to K152802 (Micro-Tech (Nanjing) Co., Ltd., 2016) and 1 other predicate after a 255-day review. Its family tree reaches back 2 generations to 2012.

Decided
Mar 27, 2020
Review
255 days
Class
Class II
Product code
OCZ
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K120084 (2012). No later device cites it as a predicate yet.

  1. Root · 2 generations backK120084 Endoscopic Retrieval DeviceUnited States Endoscopy Group, Inc. · 2012
  2. 1 generation backK152802 Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2016
  3. This deviceK191900 Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K120084Endoscopic Retrieval DeviceUnited States Endoscopy Group, Inc.2012—
−1K152802Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd.2016—
0 (this device)K191900Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd.2020—
FIG. 1 — Lineage of K191900, 2012–2020Source: 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 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 11.5 · 1 generation · no Class I recall
  2. #2 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
*K152802Grasping Forceps
Summary page 4
…cessories per 21 CFR 876.1500 Regulation class: 2 Regulation number:876.1500 Panel: Gastroenterology/Urology Product code: OCZ 3. Predicative device 3.1) 510(k) Number: K152802, Product Name: Grasping Forceps 3.2) 510(k) Number: K120084, Product Name: The US Endoscopy Endoscopic Retrieval Device 4. Devic…
Micro-Tech (Nanjing) Co., Ltd.2016—
*K120084Endoscopic Retrieval Device
Summary page 4
…number:876.1500 Panel: Gastroenterology/Urology Product code: OCZ 3. Predicative device 3.1) 510(k) Number: K152802, Product Name: Grasping Forceps 3.2) 510(k) Number: K120084, Product Name: The US Endoscopy Endoscopic Retrieval Device 4. Device description The proposed device Single Use Grasping Forcep…
United States Endoscopy Group, Inc.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 8 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
  • None of the 2 ancestors has a recall.

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. 2020, 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?

Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K191900: Single Use Grasping Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K191900

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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