Cleared Traditional

K083042 - WOUND FLUSH

K083042 · Nurse Assist, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
65d
Days
-
Risk

K083042 is an FDA 510(k) clearance for the WOUND FLUSH, STERILE WATER & NORMAL SALINE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nurse Assist, Inc. (Carrollton, US). The FDA issued a Cleared decision on December 18, 2008 after a review of 65 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 Nurse Assist, Inc. devices

FDA 510(k) Submission Details - K083042

510(k) Number K083042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date December 18, 2008
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 261
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