Cleared Traditional

K895865 - SERENE WRAP

K895865 · Byron Medical · General & Plastic Surgery device
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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

FDA 510(k) Submission Details - K895865

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 44
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K895865.
TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE
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K940210 · Visitec Co. · Mar 1994
NU-BREDE PACKING AND DEBRIDEMENT SPONGE
K921983 · Johnson & Johnson Medical, Inc. · Sep 1992
LAP SPONGE
K896801 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1989
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
K891460 · Smith & Nephew United, Inc. · Apr 1989