Cleared Traditional

K133121 - CHITO-SAM 100

K133121 · Sam Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
234d
Days
-
Risk

K133121 is an FDA 510(k) clearance for the CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SA.... Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Sam Medical Products (Wilsonville, US). The FDA issued a Cleared decision on May 22, 2014 after a review of 234 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

View all Sam Medical Products devices

FDA 510(k) Submission Details - K133121

510(k) Number K133121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date May 22, 2014
Days to Decision 234 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
119d slower than avg
Panel avg: 115d · This submission: 234d
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 47
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K133121.
Axiostat Chitosan Hemostatic Dressing
K172324 · Advamedica, Inc. · Feb 2018
Bondiloxs Topical Hemostatic Granules
K161274 · Medtrade Products , Ltd. · Jan 2017
BONDILOXS TOPICAL HEMOSTATIC DRESSING
K132333 · Medtrade Products , Ltd. · Jun 2014
CELOX GAUZE PRO
K113560 · Medtrade Products , Ltd. · Aug 2012
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
CELOX RAPID GAUZE
K110386 · Medtrade Products , Ltd. · May 2011