Home / 510(k) Clearances / K950906

510(k) K950906

LESINSKI SURGICAL EAR DRESSING by Microtek Medical, Inc. — Product Code EFQ

K950906 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "LESINSKI SURGICAL EAR DRESSING". The FDA issued a decision of Substantially Equivalent on June 22, 1995. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Microtek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1995
Date Received
February 28, 1995
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 Microtek Medical, Inc.

  • K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan (September 16, 2025)
  • K110358 — VENODYNE V810 (May 5, 2011)
  • K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK (February 23, 2011)
  • K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA (January 25, 2007)
  • K060200 — MICROTEK MEDICAL WARMING DRAPE (May 31, 2006)
  • K050322 — MICROTEK EQUIPMENT DRAPES (May 17, 2005)
  • K022903 — CHILLBUSTER (November 27, 2002)
  • K020956 — VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA (May 16, 2002)
  • K011318 — VENODYNE DVT ADVANTAGE PLUS (October 25, 2001)
  • K001802 — VENODYNE DVT ADVANTAGE MODEL 610 (January 9, 2001)

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