Home / 510(k) Clearances / K812444

510(k) K812444

RADIATION STERILIZATION FOR NEEDLE CNTR by Devon Industries, Inc. — Product Code GAB

K812444 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "RADIATION STERILIZATION FOR NEEDLE CNTR". The FDA issued a decision of Substantially Equivalent on December 14, 1981. The device falls under product code GAB (Needle, Suturing, Disposable), a Class I device regulated under 21 CFR 878.4800. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1981
Date Received
August 28, 1981
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 by Devon Industries, Inc.

  • K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) (July 3, 1996)
  • K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
  • K946289 — DEVONS POINT LOK NEEDLE PROTECTION DEVICE (July 10, 1995)
  • K944114 — PHLEBOTOMY UNIT SHARPS A GATOR (December 2, 1994)
  • K945197 — THE SHARPS COLLECTION AND DISPOSAL SYSTEM (December 2, 1994)
  • K943892 — POINT OF USE SHARPS A GATOR (December 2, 1994)
  • K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
  • K932998 — EASY-ON (August 18, 1993)
  • K912824 — DEVON SPONGE COUNTER BAGS (August 26, 1991)
  • K894170 — DEVON DISPOSABLE HEAD POSITIONER COVER (September 7, 1989)

Other clearances for product code GAB

  • K012199 — DIGICAP (December 19, 2001)
  • 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)
  • K801976 — SCANLAN STERNUM NEEDLE-SUTURE (September 26, 1980)

FDA data resources