Cleared Traditional

K081977 - PROSIT WOUND TREATMENT DEVICE

K081977 · Silverleaf Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
143d
Days
-
Risk

K081977 is an FDA 510(k) clearance for the PROSIT WOUND TREATMENT DEVICE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Silverleaf Medical Products, Inc. (Tempe, US). The FDA issued a Cleared decision on December 1, 2008 after a review of 143 days - within the typical 510(k) review window.

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 Silverleaf Medical Products, Inc. devices

FDA 510(k) Submission Details - K081977

510(k) Number K081977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2008
Decision Date December 01, 2008
Days to Decision 143 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 115d · This submission: 143d
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 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K081977.
PRUMYX CREAM
K082089 · Prugen, Inc. · Jan 2009
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
K083355 · Blairex Laboratories, Inc. · Dec 2008
WOUND FLUSH, STERILE WATER & NORMAL SALINE
K083042 · Nurse Assist, Inc. · Dec 2008
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
K080503 · Advanced Medical Solutions Limited · Nov 2008
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
K082330 · Primary Care Solutions, Inc. · Oct 2008
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
K081363 · Advanced Medical Solutions Limited · Sep 2008