Cleared Traditional

K011618 - CALGITROL AG SILVER ALGINATE WOUND DRESSING

K011618 · Adri · General & Plastic Surgery device
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Nov 2002
Decision
539d
Days
-
Risk

K011618 is an FDA 510(k) clearance for the CALGITROL AG SILVER ALGINATE WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on November 15, 2002 after a review of 539 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K011618

510(k) Number K011618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2001
Decision Date November 15, 2002
Days to Decision 539 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
424d slower than avg
Panel avg: 115d · This submission: 539d
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 685
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K011618.
SILVERLON CONTACT WOUND DRESSING
K023612 · Argentum International, LLC · Jan 2003
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K023138 · Hydrofera, LLC · Jan 2003
SILVERLON ADHESIVE STRIP
K023609 · Argentum International, LLC · Jan 2003
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · Dynarex Corp. · Oct 2002
CARRAKLENZ AND ULTRAKLENZ
K022670 · Carrington Laboratories, Inc. · Oct 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
K011618 · CALGITROL AG SILVER ALGINATE WOUND DRESSING
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