Cleared Traditional

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload (K200320) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200320 · M/s. Meril Endo Surgery Private Limited. · General & Plastic Surgery device
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Feb 2021
Decision
364d
Days
Class 2
Risk

K200320 is an FDA 510(k) clearance for the Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Ci.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on February 5, 2021 after a review of 364 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 878.4750 - 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 K200320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2020
Decision Date February 05, 2021
Days to Decision 364 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
249d slower than avg
Panel avg: 115d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 112
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K200320.
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
K201639 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · May 2021
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
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Titan SGS
K210278 · Standard Bariatrics · Apr 2021
EEA Circular Stapler with Tri-Staple Technology
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TissueTak device
K203117 · Via Surgical , Ltd. · Jan 2021
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
K202467 · Fengh Medical Co., Ltd. · Dec 2020