Cleared Traditional

K090821 - CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L

K090821 is an FDA 510(k) clearance for CHEX SINGLE USE CURVED INTRALUMINAL CIR..., manufactured by Frankenman International Limited. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K090821 · Frankenman International Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
76d
Days
Class 2
Risk

K090821 is an FDA 510(k) clearance for the CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS .... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Frankenman International Limited (Austin, US). The FDA issued a Cleared decision on June 10, 2009 after a review of 76 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 Frankenman International Limited devices

FDA 510(k) Submission Details - K090821

510(k) Number K090821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2009
Decision Date June 10, 2009
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K090821.
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