Cleared Traditional

SERENE WRAP (K895865) - FDA 510(k) Clearance

K895865 · Byron Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
86d
Days
-
Risk

K895865 is an FDA 510(k) clearance for the SERENE WRAP. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 86 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.

View all Byron Medical devices

Submission Details

510(k) Number K895865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date December 27, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K895865.
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · Johnson & Johnson Professionals, Inc. · Mar 1988
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982