Cleared Traditional

Titan SGS (K210278) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K210278 · Standard Bariatrics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
86d
Days
Class 2
Risk

K210278 is an FDA 510(k) clearance for the Titan SGS. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Standard Bariatrics (Cincinnati, US). The FDA issued a Cleared decision on April 28, 2021 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Standard Bariatrics devices

Submission Details

510(k) Number K210278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date April 28, 2021
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04086433 Completed Observational Industry-sponsored

Gastric Tissue Stapler Comparison Study

36
Patients (actual)
1
Site
Condition studied Gastric Resection
Eligibility All sexes · 18 Years+
Principal investigator Aaron B Hoffman, MD, FACS
Sponsor Standard Bariatrics (industry)
Started 2019-07-15 → Primary completion 2019-10-30
Primary outcome
Pressure Evaluation
View full study on ClinicalTrials.gov

Regulatory Peers - GDW Staple, Implantable

All 128
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K210278.
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
K210909 · Ezisurg Medical Co., Ltd. · Jun 2021
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
K202709 · Ningbo Verykind Medical Device Co., Ltd. · May 2021
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
K200320 · M/s. Meril Endo Surgery Private Limited. · Feb 2021
EEA Circular Stapler with Tri-Staple Technology
K202507 · Covidien · Jan 2021
TissueTak device
K203117 · Via Surgical , Ltd. · Jan 2021