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510(k) K920677

CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION by New Dimensions IN Medicine, Inc. — Product Code NAE

K920677 is an FDA 510(k) premarket notification submitted by New Dimensions IN Medicine, Inc. for the device "CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION". The FDA issued a decision of Substantially Equivalent on April 21, 1992. The device falls under product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic), a Class I device regulated under 21 CFR 878.4022. New Dimensions IN Medicine, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1992
Date Received
February 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Device Class
Class I
Regulation Number
878.4022
Review Panel
SU
Submission Type

Other clearances by New Dimensions IN Medicine, Inc.

  • K832145 — MONOBLOCK PROSTOPERATIVE TENS ELECTRODE (July 19, 1983)
  • K822077 — RESPIRATION MONITOR TYPE MR-10 (October 6, 1982)
  • K780631 — NDM INFANT ECG PACKPAD (May 3, 1978)
  • K780405 — INFANT ELECTROSURGICAL GROUNDING PAD (April 5, 1978)
  • K771749 — AMALGAM DISPENSER (September 28, 1977)

Other clearances for product code NAE

  • K083721 — MODIFICATION TO ZENIEVA (January 8, 2009)
  • K082865 — MODIFICATION TO ZENIEVA (October 23, 2008)
  • K073246 — ZENIEVA (July 23, 2008)
  • K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING (September 17, 1999)
  • K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (June 28, 1999)
  • K972646 — AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (August 21, 1997)
  • K971597 — COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (July 29, 1997)
  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K952945 — AQUAFLO HYDROGEL WOUND DRESSING & PACKER (August 23, 1995)
  • K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING (June 21, 1995)

FDA data resources