Cleared Traditional

K970441 - K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH

K970441 is an FDA 510(k) clearance for K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8..., manufactured by Medi-Flex Hospital Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FPX cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K970441 · Medi-Flex Hospital Products, Inc. · General & Plastic Surgery device
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May 1997
Decision
93d
Days
Class 1
Risk

K970441 is an FDA 510(k) clearance for the K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. 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 Medi-Flex Hospital Products, Inc. devices

FDA 510(k) Submission Details - K970441

510(k) Number K970441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1997
Decision Date May 09, 1997
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

FPX Device Classification - Class 1, General Controls

Product Code FPX Strip, Adhesive, Closure, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FPX Strip, Adhesive, Closure, Skin

All 21
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K970441.
TECNOL SILK STRIP
K894205 · Tecnol New Jersey Wound Care, Inc. · Jul 1989
DERMA STRIP-TM SKIN CLOSURES
K833083 · Howmedica Corp. · Dec 1983
ELASTOPLAST
K831438 · Beiersdorf, Inc. · Nov 1983
ELASTOPLAST T.P.N.
K831439 · Beiersdorf, Inc. · Sep 1983
CENTRAL VENOUS CATHETER DRESSING TRAY
K802384 · American Medical Disposable, Inc. · Nov 1980
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
K802385 · American Medical Disposable, Inc. · Nov 1980