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510(k) K791872

LAP SPONGES by Carwild Corp. — Product Code EFQ

K791872 is an FDA 510(k) premarket notification submitted by Carwild Corp. for the device "LAP SPONGES". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Carwild Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
September 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Carwild Corp.

  • K913303 — LAP SPONGES, MODIFIED (August 6, 1992)
  • K913302 — DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED (July 23, 1992)
  • K833688 — SUTURE REMOVAL KITS STERILE (May 31, 1984)
  • K791871 — NEUROLOGICAL SPONGES (PATTIES) (November 5, 1979)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources