Home / 510(k) Clearances / K020781

510(k) K020781

WET CHAMBER by Kinetic Concepts, Inc. — Product Code NAD

K020781 is an FDA 510(k) premarket notification submitted by Kinetic Concepts, Inc. for the device "WET CHAMBER". The FDA issued a decision of Substantially Equivalent on May 6, 2002. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Kinetic Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2002
Date Received
March 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Kinetic Concepts, Inc.

  • K050261 — V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (May 26, 2005)
  • K041642 — V.A.C. GRANUFOAM SILVER DRESSING (January 25, 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)
  • 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 NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)
  • K960815 — DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSIN (April 29, 1996)

FDA data resources