510(k) Report

Devices descending from K133276

9 later devices reach V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…Deroyal Industries, Inc.20250—
+1K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc.20240—
+1K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing LargeSmith and Nephew Medical Limited20231—
+1K181505V.A.C. DERMATAC DrapeKci USA, Inc.20195—
+2K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small…3M Healthcare Business Group20211—
+2K200390V.A.C. DERMATAC DrapeKci USA, Inc.20202—
+3K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…3M Healthcare Business Group20230—
+3K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place…3M20230—
+3K220560Dermatac Drape3M20220—