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510(k) K041642

V.A.C. GRANUFOAM SILVER DRESSING by Kinetic Concepts, Inc. — Product Code OMP

K041642 is an FDA 510(k) premarket notification submitted by Kinetic Concepts, Inc. for the device "V.A.C. GRANUFOAM SILVER DRESSING". The FDA issued a decision of Substantially Equivalent on January 25, 2005. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Kinetic Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2005
Date Received
June 17, 2004
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 Kinetic Concepts, Inc.

  • K050261 — V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (May 26, 2005)
  • K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (October 10, 2003)
  • K022011 — V.A.C. ABDOMINAL DRESSING (February 26, 2003)
  • K021500 — VACUUM ASSISTED CLOSURE (December 20, 2002)
  • K021501 — V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT (December 2, 2002)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K992448 — V.A.C. PLUS (January 18, 2000)
  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K972549 — SIMPULSE (November 18, 1997)
  • K955243 — BARIAIR (October 23, 1997)

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