Cleared Traditional

SURGIAID (K100927) - FDA 510(k) Clearance

K100927 · Maxigen Biotech, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
303d
Days
-
Risk

K100927 is an FDA 510(k) clearance for the SURGIAID. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Maxigen Biotech, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 303 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.

View all Maxigen Biotech, Inc. devices

Submission Details

510(k) Number K100927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2010
Decision Date February 02, 2011
Days to Decision 303 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
188d slower than avg
Panel avg: 115d · This submission: 303d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 74
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K100927.
Cytal Wound Particulate
K180776 · Acell, Inc. · May 2018
XCelliStem Wound Powder
K172593 · Stemsys · Mar 2018
ologen Collagen Matrix
K173223 · Aeon Astron Europe B.V. · Mar 2018
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc. · Jun 2006