Search Results
Found 2 results
510(k) Data Aggregation
K Number
K190129Device Name
AC5 Topical Gel
Manufacturer
Arch Therapeutics, Inc.
Date Cleared
2020-03-11
(408 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Arch Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full- thickness wounds, such as pressure sores, leg ulcers, and surgical wounds.
Device Description
AC5 Topical Gel is configured as a package containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).
Ask a Question
K Number
K182681Device Name
AC5 Topical Gel
Manufacturer
Arch Therapeutics, Inc.
Date Cleared
2018-12-14
(79 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Arch Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, diabetic ulcers, and surgical wounds.
Device Description
AC5 Topical Gel is configured as a kit containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).
Ask a Question
Page 1 of 1