510(k) · Cleared

Cleared

Mirus Ligating Clip, Mirus Ligating Clip Applier

K200166510(k) TraditionalCleared Nov 23, 2020306-day reviewClass II21 CFR 878.4300

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

M/s. Meril Endo Surgery Private Limited. · FZP Clip, Implantable

Cleared on Nov 23, 2020 as substantially equivalent to K834267 (ETHICON, Inc., 1984) and 1 other predicate after a 306-day review. Its family tree reaches back 1 generation to 1984. 7 later devices descend from it.

Decided: Nov 23, 2020
Review: 306 days
Class: Class II
Product code: FZP
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K834267 (1984). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK834267 Ligaclip Metallic Ligating ClipETHICON, Inc. · 1984
This deviceK200166 Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited. · 2020
Descendant · cites it directly · 6 of its ownK212127 PicocaremajestyWontech Co., Ltd. · 2022
Descendant · 2 generations on · 2 of its ownK233018 PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023
Descendant · 2 generations on · 1 of its ownK233007 Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024
Descendant · 2 generations on · 0 of its ownK253829 Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd. · 2026
Descendant · 3 generations on · 0 of its ownK252345 Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2022high 3 (2024) · low 1 (2022)2026

Most influential descendants

Showing 5 of 7 · See all

K212127PicocaremajestyWontech Co., Ltd. · 2022 · cites it directly6descendants
K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023 · 2 generations on2descendants
K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024 · 2 generations on1descendant
K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd. · 2026 · 2 generations on0descendants
K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K834267	Ligaclip Metallic Ligating Clip	ETHICON, Inc.	1984	—
0 (this device)	K200166	Mirus Ligating Clip, Mirus Ligating Clip Applier	M/s. Meril Endo Surgery Private Limited.	2020	—
+1	K212127	Picocaremajesty	Wontech Co., Ltd.	2022	—
+2	K233018	PICOSECOND Nd:YAG Laser System	Ids, Ltd.	2023	—
+2	K233007	Picosecond Nd:YAG Laser System; PICO LEGEND	Ami, Inc.	2024	—
+2	K253829	Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)	Beijing HuaCheng Taike Technology Co., Ltd.	2026	—
+3	K252345	Picosecond Laser Device (PF131-BI)	Risu Medical Technology Co., Ltd.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2023	1	0
2024	3	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K200166, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FZP? 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 FZP device

#1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K834267	Ligaclip Metallic Ligating Clip Summary page 4 …878.4300 21 CER 878.4800 Classification Class II Class I Product Code FZP GAG III. Predicate Device K834267: Ligaclip™ Titanium Ligating Clip, Ethicon, Inc.(Primary Predicate Device) K982313: Horizon™ Titanium Clips, Weck Closure Sy…	ETHICON, Inc.	1984	—
*	K982313	Horizon Titanium Clips, Horizon Tantalum Clips Summary page 4 …Product Code FZP GAG III. Predicate Device K834267: Ligaclip™ Titanium Ligating Clip, Ethicon, Inc.(Primary Predicate Device) K982313: Horizon™ Titanium Clips, Weck Closure Systems…	Weck Closure Systems	1998	1

Also cleared against K834267: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K212127	Picocaremajesty	Wontech Co., Ltd.	2022	6

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K212127 (Wontech Co., Ltd., 2022) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K834267.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · FZP

5in 2025

2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007high 227 (2022) · low 22 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FZP

1in 2020

2007high 6 (2008) · low 0 (2009)2026

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

Adverse event reports per year · FZP

1,902in 2025

2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, 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	6	31	1	1,877
2008	4	23	6	981
2009	3	22	0	2,160
2010	6	47	1	2,367
2011	3	124	0	1,678
2012	2	—	1	1,677
2013	3	47	0	2,381
2014	3	29	1	2,320
2015	8	182	0	2,871
2016	5	72	2	1,840
2017	4	29	1	2,594
2018	4	143	0	2,718
2019	1	—	3	2,903
2020	2	—	1	1,760
2021	0	—	0	1,759
2022	3	227	0	1,575
2023	3	65	0	1,918
2024	2	—	0	2,067
2025	5	90	0	1,902
2026	2	—	0	—

What is it indicated for?

The MirusTm Ligating clip is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with size of the clip.

MirusTMLigating Clip applier is intended to apply ligating clips on tubular structures or vessels wherever a metal ligating clip is indicated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200166 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200166: Mirus Ligating Clip, Mirus Ligating Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200166

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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