Home / 510(k) Clearances / K912824

510(k) K912824

DEVON SPONGE COUNTER BAGS by Devon Industries, Inc. — Product Code LWH

K912824 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "DEVON SPONGE COUNTER BAGS". The FDA issued a decision of Substantially Equivalent on August 26, 1991. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
June 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Sponge, Surgical
Device Class
Class I
Regulation Number
880.2740
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)
  • K894170 — DEVON DISPOSABLE HEAD POSITIONER COVER (September 7, 1989)
  • K892660 — HIBERNATION KIT (August 15, 1989)

Other clearances for product code LWH

  • K121274 — PIXEL APP (June 27, 2012)
  • K120473 — PIXEL APP (April 9, 2012)
  • K100551 — ORLOCATE SYSTEM MODEL ORL 100 (August 12, 2010)
  • K093557 — SMARTWAND-DTX (December 18, 2009)
  • K073180 — SMARTSPONGE PLUS SYSTEM (November 19, 2007)
  • K071355 — SMARTSPONGE SYSTEM (May 24, 2007)
  • K062642 — RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (November 2, 2006)
  • K061316 — MEDLINE SURGICAL SPONGE SCANNER (November 2, 2006)
  • K060076 — SURGICOUNT SAFETY-SPONGE SYSTEM (March 14, 2006)
  • K982260 — MARKWELL GAUZE SPONGE (August 12, 1998)

FDA data resources