Cleared Special

Reach and CQ'ENCE Circular Staplers (K192566) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192566 · Reach Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
29d
Days
Class 2
Risk

K192566 is an FDA 510(k) clearance for the Reach and CQ'ENCE Circular Staplers. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Reach Surgical, Inc. (Tianjin, CN). The FDA issued a Cleared decision on October 17, 2019 after a review of 29 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reach Surgical, Inc. devices

Submission Details

510(k) Number K192566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2019
Decision Date October 17, 2019
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Secqure Surgical
Rich Grant

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GDW Staple, Implantable

All 282
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K192566.
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K252739 · Ethicon Endo-Surgery, LLC · Dec 2025
ETHICON 4000 60mm Compact Stapler (EC3D60C)
K250835 · Ethicon Endo-Surgery, LLC · May 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · Ethicon Endo-Surgery, LLC · Feb 2025
ECHELON 4000 60mm Compact Stapler (EC3D60C)
K241630 · Ethicon Endo-Surgery, LLC · Oct 2024