Cleared Traditional

K063190 - SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC

K063190 · Noble Fiber Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
305d
Days
-
Risk

K063190 is an FDA 510(k) clearance for the SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Noble Fiber Technologies, Inc. (Scranton, US). The FDA issued a Cleared decision on August 21, 2007 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

FDA 510(k) Submission Details - K063190

510(k) Number K063190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2006
Decision Date August 21, 2007
Days to Decision 305 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 115d · This submission: 305d
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 K063190.
QUIKCLOT EX
K072474 · Z-Medica Corporation · Oct 2007
BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
K071578 · Lifescience Plus, Inc. · Sep 2007
WOUNDSTAT, MODEL TC1001
K071936 · Traumacure, Inc. · Aug 2007
HEMCON CHITOFLEX-SURGICAL DRESSING
K071519 · Hemcon, Inc. · Aug 2007
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
K070175 · Medtrade Products , Ltd. · Jul 2007
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
K070211 · Hemostasis, LLC · Apr 2007
K063190 · SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
Download PDF FDA Summary Noble Fiber Technolog…