Cleared Traditional

K943363 - CUTIPLAST STERIL

K943363 · Beiersdorf, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
245d
Days
-
Risk

K943363 is an FDA 510(k) clearance for the CUTIPLAST STERIL. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 245 days - an extended review 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: 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K943363

510(k) Number K943363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date March 15, 1995
Days to Decision 245 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
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 12
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K943363.
EPIVIEW
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ULTEC THIN HYDROCOLLOID DRESSING
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K950065 · Conmedcorp · 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