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510(k) K894984

MASCOT LAB SPONGE by Mascot, Inc. — Product Code GDY

K894984 is an FDA 510(k) premarket notification submitted by Mascot, Inc. for the device "MASCOT LAB SPONGE". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Mascot, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
August 8, 1989
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 Mascot, Inc.

  • K903500 — MASCOT THERMOTER (October 9, 1990)
  • K894587 — MASCOT EXAMINATION GLOVES (October 4, 1989)
  • K894436 — MASCOT O.R. TOWEL (August 11, 1989)

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)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)

FDA data resources