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510(k) K802798

OPRATEX ABDOMINAL PAD by Secol Co. — Product Code GDY

K802798 is an FDA 510(k) premarket notification submitted by Secol Co. for the device "OPRATEX ABDOMINAL PAD". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Secol Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
November 4, 1980
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 Secol Co.

  • K802790 — SOLVALINE (February 13, 1981)
  • K810111 — CELLONA PLASTER VARNISH (February 4, 1981)
  • K810109 — METAL SPLINTS (January 26, 1981)
  • K810110 — COBBLER'S CHIP SPLINTS (January 26, 1981)
  • K802794 — PRO-OPHTA STICKS (December 22, 1980)
  • K802793 — LOMATUELL OINTMENT DRESSING (December 18, 1980)
  • K802787 — METALLINE DRESSINGS (December 17, 1980)
  • K802799 — EYE PADS (December 17, 1980)
  • K802791 — ZINC PASTE BANDAGE (December 17, 1980)
  • K802786 — POROPLAST-EYE DRESSING (December 17, 1980)

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