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510(k) K772089

LAPAROTOMY SPOGNE by General Medical Co. — Product Code EFQ

K772089 is an FDA 510(k) premarket notification submitted by General Medical Co. for the device "LAPAROTOMY SPOGNE". The FDA issued a decision of Substantially Equivalent on November 11, 1977. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. General Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 11, 1977
Date Received
November 4, 1977
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 General Medical Co.

  • K926269 — PROCEDURE KIT (August 27, 1993)
  • K912975 — OPERAND LUBRICATING JELLY (September 27, 1991)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K903669 — GENESIS INSUFFLATING CATHETER (September 12, 1990)
  • K900110 — OPERAND* LUBRICATING JELLY (May 2, 1990)
  • K853635 — SUBDERM TM (December 20, 1985)
  • K844652 — C.A.S.E. CONTAINER (December 12, 1984)
  • K831320 — DRIONIC (July 19, 1983)
  • K820689 — C.S.R. WRAPPERS (April 9, 1982)
  • K820521 — STERILIZATION WRAP (March 18, 1982)

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