Cleared Traditional

K072890 - STASILON FR

K072890 · Entegrion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
61d
Days
-
Risk

K072890 is an FDA 510(k) clearance for the STASILON FR. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Entegrion, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on December 10, 2007 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

FDA 510(k) Submission Details - K072890

510(k) Number K072890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2007
Decision Date December 10, 2007
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K072890.
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
K080818 · Hem Con Medical Technologies, Inc. · May 2008
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
K080648 · Ore-Medix, LLC · May 2008
MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT
K072328 · Medtrade Products , Ltd. · Dec 2007
BLOODSTOP HEMOSTATIC GAUZE
K072681 · Lifescience Plus, Inc. · Nov 2007
EXCELARREST FOAM
K072900 · Hemostasis, LLC · Oct 2007
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
K070520 · Biolife, LLC · Oct 2007
K072890 · STASILON FR
Download PDF FDA Summary Entegrion, Inc.