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510(k) K020753

DEROYAL SURGICAL, UMBILICUP by Deroyal — Product Code KSR

K020753 is an FDA 510(k) premarket notification submitted by Deroyal for the device "DEROYAL SURGICAL, UMBILICUP". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100. Deroyal has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
March 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class
Class II
Regulation Number
864.9100
Review Panel
HE
Submission Type

Other clearances by Deroyal

  • K041416 — EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (July 2, 2004)
  • K033057 — DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE (November 20, 2003)
  • K031408 — DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) (October 15, 2003)
  • K030908 — DEROYAL SURGICAL DRAPES BACKTABLE COVER (August 11, 2003)

Other clearances for product code KSR

  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)
  • K810500 — BLOOD FREEZING BAG (September 23, 1981)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K811523 — PLASMA FLEX (September 9, 1981)
  • K811449 — HAEMONETICS 1000ML COMPONENT BAG (July 1, 1981)
  • K810711 — HAEMONETICS 600 ML. COMPONENT BAG (May 8, 1981)
  • K810313 — HAEMONETICS 1400 ML THERAPEUTIC BAG (March 31, 1981)
  • K801082 — GAMBRO HEMOFREEZE-BAG (October 31, 1980)
  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K792395 — PHARMAFLEX CRYOGENIC BAG (February 26, 1980)

FDA data resources