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510(k) K912472

DEROYAL WOUND DRESSING by Deroyal Industries, Inc. — Product Code MGO

K912472 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "DEROYAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on October 2, 1991. The device falls under product code MGO (Closure, Wound, Adhesive), a Class I device regulated under 21 CFR 878.4018. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1991
Date Received
June 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Closure, Wound, Adhesive
Device Class
Class I
Regulation Number
878.4018
Review Panel
SU
Submission Type

Other clearances by Deroyal Industries, Inc.

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  • K230233 — Prospera Spectruum Negative Pressure Wound Therapy System (April 18, 2024)
  • K200631 — DeRoyal Temperature Monitoring Probe (December 23, 2020)
  • K200757 — Foley Catheter with Temperature Sensor (October 15, 2020)
  • K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal St (April 2, 2020)
  • K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Su (April 2, 2020)
  • K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover (January 21, 2020)
  • K173072 — Algidex Ag Silver Alginate Wound Dressing (April 4, 2018)
  • K171475 — DeRoyal Laprador Specimen Retrieval System (August 17, 2017)
  • K152978 — DeRoyal Angiography Kits (March 25, 2016)

FDA data resources