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510(k) K141033

SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV by Argentum Medical, LLC — Product Code OMP

K141033 is an FDA 510(k) premarket notification submitted by Argentum Medical, LLC for the device "SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV". The FDA issued a decision of Substantially Equivalent on September 12, 2014. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Argentum Medical, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2014
Date Received
April 22, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Other clearances by Argentum Medical, LLC

  • K241225 — Silverlon® Wound Contact, Burn Contact Dressing (July 31, 2024)
  • K221218 — Silverlon Wound Contact, Burn Contact Dressings (October 26, 2022)
  • K190343 — Silverlon Wound Contact, Burn Contact Dressings (July 18, 2019)
  • K180570 — Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Sil (January 14, 2019)
  • K150256 — SILVERLON BURN CONTACT DRESSINGS (April 30, 2015)
  • K143001 — SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING (November 7, 2014)
  • K141573 — SILVERLON ISLAND WOUND DRESSING (August 28, 2014)
  • K122817 — SILVERLON ISLAND WOUND DRESSING (May 1, 2014)
  • K053590 — SILVERLON CA (CALCIUM ALGINATE) (October 6, 2006)

Other clearances for product code OMP

  • K253263 — ConvaVAC™ Negative Pressure Wound Therapy System (June 24, 2026)
  • K253199 — CURASYS 2 (EMDN0003) (June 23, 2026)
  • K260646 — RENASYS EDGE (66803126) (May 27, 2026)
  • K261291 — Nisus NPWT Canister 500-mL (CPC-500) (May 21, 2026)
  • K254019 — Wound Geni NPWT System (May 4, 2026)
  • K253429 — Genadyne ASTRA NPWT (March 12, 2026)
  • K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foa (November 21, 2025)
  • K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System (October 3, 2025)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (September 11, 2025)
  • K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (June 27, 2025)

FDA data resources