Home / 510(k) Clearances / K861215

510(k) K861215

GAUZE SPONGES USP TYPE VII by Selomas, Inc. — Product Code EFQ

K861215 is an FDA 510(k) premarket notification submitted by Selomas, Inc. for the device "GAUZE SPONGES USP TYPE VII". The FDA issued a decision of Substantially Equivalent on April 17, 1986. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Selomas, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1986
Date Received
March 31, 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 Selomas, Inc.

  • K821258 — SELOPOR (August 19, 1982)
  • K821260 — VITOFIT (June 23, 1982)
  • K821259 — VITASAN (June 23, 1982)
  • K821490 — SILKAFIX ADHESIVE PLASTER (June 2, 1982)
  • K821257 — SELOFIX (May 14, 1982)
  • K812501 — OPRAFLEX (October 2, 1981)

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