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510(k) K863737

SPONGES STERILE TWIN PAKT AND SINGLES by Hermitage Hospital Products, Inc. — Product Code EFQ

K863737 is an FDA 510(k) premarket notification submitted by Hermitage Hospital Products, Inc. for the device "SPONGES STERILE TWIN PAKT AND SINGLES". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Hermitage Hospital Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
September 23, 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 Hermitage Hospital Products, Inc.

  • K941802 — OR TOWEL (May 3, 1995)
  • K923115 — CLINISORB (November 23, 1992)
  • K923116 — COMBINE II WETPROOF PAD (October 6, 1992)
  • K891324 — HERMITEX SPONGE (April 27, 1989)
  • K843788 — CUSTOM BURN DRESSING KIT (November 7, 1984)
  • K822987 — DRESSING SPONGE (November 5, 1982)
  • K822623 — LAPAROTOMY SPONGE (October 13, 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