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510(k) K012199

DIGICAP by Humana USA, Inc. — Product Code GAB

K012199 is an FDA 510(k) premarket notification submitted by Humana USA, Inc. for the device "DIGICAP". The FDA issued a decision of Substantially Equivalent on December 19, 2001. The device falls under product code GAB (Needle, Suturing, Disposable), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2001
Date Received
July 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Suturing, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code GAB

  • K980988 — AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (May 11, 1998)
  • K932591 — ENDO-JUDGE (December 22, 1993)
  • K895681 — CONTRAST BACKGROUND MATERIAL (October 24, 1989)
  • K863595 — COATED SUTURE NEEDLE (October 24, 1986)
  • K831648 — ANCHOR BRAND SURGICAL NEEDLES (August 16, 1983)
  • K812444 — RADIATION STERILIZATION FOR NEEDLE CNTR (December 14, 1981)
  • K801976 — SCANLAN STERNUM NEEDLE-SUTURE (September 26, 1980)

FDA data resources