Home / 510(k) Clearances / K802940

510(k) K802940

SUPER-SPIKE TRANSFER SET by Geneva Laboratories, Inc. — Product Code KSB

K802940 is an FDA 510(k) premarket notification submitted by Geneva Laboratories, Inc. for the device "SUPER-SPIKE TRANSFER SET". The FDA issued a decision of Substantially Equivalent on January 15, 1981. The device falls under product code KSB (Set, Transfer (Blood/Plasma)), a Class II device regulated under 21 CFR 864.9875. Geneva Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1981
Date Received
November 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Transfer (Blood/Plasma)
Device Class
Class II
Regulation Number
864.9875
Review Panel
HE
Submission Type

Other clearances by Geneva Laboratories, Inc.

  • K881217 — GENT-L-KARE STERILE URINARY LEG BAG (July 29, 1988)
  • K881213 — GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER (July 28, 1988)
  • K881218 — GENT-L-KARE CLEANSING ENEMA SET (July 28, 1988)
  • K881216 — GENT-L-KARE VAGINAL IRRIGATION SET (June 7, 1988)
  • K861308 — ACCUPAC CUSTOM PACK KERLIX SQUARES (May 2, 1986)
  • K861219 — ACCUPAC CUSTOM SKIN SCRUB KIT (April 15, 1986)
  • K853265 — ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 (August 26, 1985)
  • K843206 — COOK COUNTY HOSPITAL DRESSING CHANGE SET (May 24, 1985)
  • K844255 — GENT-L-KARE STERILE I.V. START KIT (December 19, 1984)
  • K843090 — UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM (December 4, 1984)

Other clearances for product code KSB

  • K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System (September 28, 2018)
  • K001043 — KAWASUMI LABORATORY BLOOD DRAWING KIT (May 19, 2000)
  • K820447 — ALPHA PLASMA TRANSFER SET (April 14, 1982)
  • K791131 — FLU VEN TR-1 (September 4, 1979)
  • K791130 — FLU-VEN TK-2 (September 4, 1979)

FDA data resources