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510(k) K863761

2X2 SPONGES, NON-STERILE, COTTON FILLED by The Medical Group, Inc. — Product Code EFQ

K863761 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "2X2 SPONGES, NON-STERILE, COTTON FILLED". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. The Medical Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
September 25, 1986
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 The Medical Group, Inc.

  • K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (June 6, 1991)
  • K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM (March 30, 1990)
  • K881843 — PEDIATRIC HOSPITAL BED (October 26, 1988)
  • K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM (July 14, 1988)
  • K870283 — 3 X 3 SPONGES, NON-STERILE (February 24, 1987)
  • K870284 — TRIANGULAR BANDAGE (February 24, 1987)
  • K870282 — 4 X 4 SPONGES, NON-STERILE (February 24, 1987)
  • K870285 — THERMOMETER SHEATHES, STERILE (GLASS) (February 12, 1987)
  • K863769 — EVACUATOR TIPS (October 30, 1986)
  • K863767 — GLASS MOUTH MIRRORS, REUSABLE (October 30, 1986)

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