Cleared Traditional

AC5 Topical Gel (K182681) - FDA 510(k) Clearance

K182681 · Arch Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
79d
Days
-
Risk

K182681 is an FDA 510(k) clearance for the AC5 Topical Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Arch Therapeutics, Inc. (Framingham, US). The FDA issued a Cleared decision on December 14, 2018 after a review of 79 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 Arch Therapeutics, Inc. devices

Submission Details

510(k) Number K182681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2018
Decision Date December 14, 2018
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Clinical Evidence

ClinicalTrials.gov
NCT02704104 Completed Interventional Industry-sponsored

Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions

A Randomized Controlled Single-Blind Investigation to Evaluate the Safety and Performance of the AC5 Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions

46
Patients (actual)
1
Site
Supportive_care
Purpose
Single blind
Masking
Condition studied Skin Neoplasms
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Jack Kelly, MD
Sponsor Arch Therapeutics (industry)
Started 2016-02-01 → Primary completion 2016-06-01
Primary outcome
Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up
Secondary outcome
Median Time to Hemostasis (Seconds)
View full study on ClinicalTrials.gov

Regulatory Peers - FRO Dressing, Wound, Drug

All 701
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