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510(k) K951911

GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) by Commercial Resources New Mexico, Ltd. — Product Code GDY

K951911 is an FDA 510(k) premarket notification submitted by Commercial Resources New Mexico, Ltd. for the device "GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
April 24, 1995
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 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