Home / 510(k) Clearances / K913794

510(k) K913794

SIMPEX INC. SURGICAL DRESSING by Simpex, Inc. — Product Code GDY

K913794 is an FDA 510(k) premarket notification submitted by Simpex, Inc. for the device "SIMPEX INC. SURGICAL DRESSING". The FDA issued a decision of Substantially Equivalent on November 20, 1991. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Simpex, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1991
Date Received
August 23, 1991
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 Simpex, Inc.

  • K920174 — EASY TOUCH LATEX EAM GLOVES (April 22, 1992)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)
  • K911505 — FIXATION WIRE (April 12, 1991)
  • K911452 — FIXATION PIN (April 12, 1991)

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)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)

FDA data resources