Cleared Traditional

K200166 - Mirus Ligating Clip

K200166 is the FDA 510(k) clearance for Mirus Ligating Clip by M/s. Meril Endo Surgery Private Limited.. It is a Class 2 General & Plastic Surgery device (product code FZP) cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K200166 · M/s. Meril Endo Surgery Private Limited. · General & Plastic Surgery device
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Nov 2020
Decision
306d
Days
Class 2
Risk

K200166 is an FDA 510(k) clearance for the Mirus Ligating Clip, Mirus Ligating Clip Applier. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on November 23, 2020 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all M/s. Meril Endo Surgery Private Limited. devices

Submission Details

510(k) Number K200166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2020
Decision Date November 23, 2020
Days to Decision 306 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 115d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 96
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K200166.
DuraFuse Clip and Applier System
K213813 · Neuramedica, Inc. · Jul 2022
angioLOCK Polymer Ligating Clip
K220006 · A2 Medical Systems, LLC · Mar 2022
InnoClip Disposable Clip Applier, InnoClip Clip Applier
K202994 · Taiwan Surgical Corporation · Jan 2022
Aesculap PAS-Port Proximal Anastomosis System
K202124 · Aesculap, Inc. · Sep 2020
Dannik Titanium Ligation Clip
K192711 · Dannik · Dec 2019
Amsel Endo Occluder
K180650 · Amsel Medical Corporation · Nov 2018