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510(k) K810184

LAPAROTOMY SPONGE by Medical Action Industries, Inc. — Product Code GDY

K810184 is an FDA 510(k) premarket notification submitted by Medical Action Industries, Inc. for the device "LAPAROTOMY SPONGE". The FDA issued a decision of Substantially Equivalent on February 4, 1981. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Medical Action Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1981
Date Received
January 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by Medical Action Industries, Inc.

  • K042526 — DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON S (April 25, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)
  • K022948 — VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L (November 4, 2002)
  • K946019 — SURGICLA INSTRUMENT KIT (March 20, 1995)
  • K923846 — BURN DRESSING (September 11, 1992)
  • K884826 — GAUZE SPONGE (December 22, 1988)
  • K810685 — SUTURE REMOVAL KIT (March 26, 1981)

Other clearances for product code GDY

  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)

FDA data resources