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510(k) K941344

LAP SPONGE PRODUCT LINE by Cush Medical Products — Product Code GDY

K941344 is an FDA 510(k) premarket notification submitted by Cush Medical Products for the device "LAP SPONGE PRODUCT LINE". The FDA issued a decision of Substantially Equivalent on May 12, 1994. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Cush Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1994
Date Received
March 17, 1994
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 Cush Medical Products

  • K943424 — CUSH ISLAND DRESSING (October 3, 1994)
  • K940518 — C-SECTION TRAY (August 18, 1994)
  • K941349 — DENTAL TRAY (July 26, 1994)
  • K941645 — BIOPSY TRAY (July 14, 1994)
  • K940239 — EYE TRAY (June 28, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K941455 — STERILE GAUZE PRODUCT LINE (May 20, 1994)
  • K941522 — STERILE X-RAY DETECTABLE GAUZE SPONGES (May 12, 1994)
  • K935697 — CIRCUMCISION TRAY (May 2, 1994)
  • K936120 — LABOR AND DELIVERY TRAY (March 30, 1994)

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)
  • K953059 — KITTNER DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)

FDA data resources