Cleared Traditional

K943424 - CUSH ISLAND DRESSING

K943424 · Cush Medical Products · General & Plastic Surgery device
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Oct 1994
Decision
80d
Days
-
Risk

K943424 is an FDA 510(k) clearance for the CUSH ISLAND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 80 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 Cush Medical Products devices

FDA 510(k) Submission Details - K943424

510(k) Number K943424 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 15, 1994
Decision Date October 03, 1994
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 13
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K943424.
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995
CUTIPLAST STERIL
K943363 · Beiersdorf, Inc. · Mar 1995
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
K942774 · The Kendal Co. · Jul 1994
CUTIFILM(R) FILM
K926399 · Beiersdorf, Inc. · Nov 1993
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · Deroyal Industries, Inc. · Jul 1992