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510(k) K913303

LAP SPONGES, MODIFIED by Carwild Corp. — Product Code GDY

K913303 is an FDA 510(k) premarket notification submitted by Carwild Corp. for the device "LAP SPONGES, MODIFIED". The FDA issued a decision of Substantially Equivalent on August 6, 1992. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Carwild Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1992
Date Received
July 25, 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 Carwild Corp.

  • K913302 — DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED (July 23, 1992)
  • K833688 — SUTURE REMOVAL KITS STERILE (May 31, 1984)
  • K791872 — LAP SPONGES (November 13, 1979)
  • K791871 — NEUROLOGICAL SPONGES (PATTIES) (November 5, 1979)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)

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