Cleared Traditional

K936230 - DERMASSIST PETROLATUM GAUZE,USP

K936230 · Wilshire Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
64d
Days
-
Risk

K936230 is an FDA 510(k) clearance for the DERMASSIST PETROLATUM GAUZE,USP. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Wilshire Medical Products (Dallas, US). The FDA issued a Cleared decision on March 3, 1994 after a review of 64 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 Wilshire Medical Products devices

FDA 510(k) Submission Details - K936230

510(k) Number K936230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date March 03, 1994
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 587
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K936230.
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
K932676 · Polymedica Industries, Inc. · Dec 1993
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993