Atlas FDA

DEROYAL SURGICAL, UMBILICUP

FDA 510(k) clearance K020753 · decided 2002-06-13

Clearance details

K-number
K020753
Device name
DEROYAL SURGICAL, UMBILICUP
Applicant
Deroyal
Decision
Substantially Equivalent
Date received
2002-03-07
Decision date
2002-06-13
Days to decision
98 days
Clearance type
Traditional
Product code
KSR
Device class
2
Regulation number
864.9100
Medical specialty
Hematology
Advisory committee
Hematology
Location
Powell, TN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (K032827)Tyco Healthcare2003-12-08
ALPHA PLASTIC PLASMA BOTTLE (K810897)Alpha Therapeutic Corp.1981-09-23
BLOOD FREEZING BAG (K810500)Delmed, Inc.1981-09-23
PLASMA FLEX (K811523)Terumo America, Inc.1981-09-09
HAEMONETICS 1000ML COMPONENT BAG (K811449)Haemonetics Corp.1981-07-01
HAEMONETICS 600 ML. COMPONENT BAG (K810711)Haemonetics Corp.1981-05-08
HAEMONETICS 1400 ML THERAPEUTIC BAG (K810313)Haemonetics Corp.1981-03-31
GAMBRO HEMOFREEZE-BAG (K801082)Gambro, Inc.1980-10-31
PLASMAPOOLER (K801219)North American Biologicals, Inc.1980-10-31
PHARMAFLEX CRYOGENIC BAG (K792395)Pharmachem Corp.1980-02-26
PIASMA SAFE (K792185)Cry-O-Safe, Inc.1979-12-28
EMPTY TRANSFER BAG (K791673)Delmed, Inc.1979-10-23

Recalls involving this device

RecordFirmDate
DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, recall (Z-1396-2012)DeRoyal Industries Inc2012-04-12
DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 P recall (Z-1398-2012)DeRoyal Industries Inc2012-04-12