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510(k) K831703

COVERUPS by The Urology Group — Product Code NAD

K831703 is an FDA 510(k) premarket notification submitted by The Urology Group for the device "COVERUPS". The FDA issued a decision of Substantially Equivalent on January 3, 1984. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. The Urology Group has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
May 25, 1983
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 The Urology Group

  • K831489 — SURGICAL TUBE HOLDER (December 12, 1983)
  • K810739 — SUCTION WOUND DRAINAGE DEVICE (June 26, 1981)
  • K810788 — SURGICAL TUBE HOLDER (April 17, 1981)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)
  • K801629 — COVER-ALL MALE INCONTINENCE DEVICE (August 12, 1980)

Other clearances for product code NAD

  • K254246 — LT Antibacterial Foam with Silver Dressing (September 10, 2026)
  • 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)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)

FDA data resources