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510(k) K913302

DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED by Carwild Corp. — Product Code GDY

K913302 is an FDA 510(k) premarket notification submitted by Carwild Corp. for the device "DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED". The FDA issued a decision of Substantially Equivalent on July 23, 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
July 23, 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.

  • K913303 — LAP SPONGES, MODIFIED (August 6, 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)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953088 — TRIANGULAR SPONGES (September 14, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)

FDA data resources