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510(k) K033796

KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS by Heinz Kurz GmbH Medizintechnik — Product Code KHJ

K033796 is an FDA 510(k) premarket notification submitted by Heinz Kurz GmbH Medizintechnik for the device "KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS". The FDA issued a decision of Substantially Equivalent on January 30, 2004. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Heinz Kurz GmbH Medizintechnik has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2004
Date Received
December 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Heinz Kurz GmbH Medizintechnik

  • K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES P (December 2, 2013)
  • K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (February 8, 2013)
  • K071150 — TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076 (December 12, 2007)
  • K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (October 1, 2004)
  • K021479 — CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (May 21, 2002)
  • K013573 — CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 (November 9, 2001)
  • K011115 — KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL (May 2, 2001)
  • K002221 — KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 (August 9, 2000)
  • K001123 — KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 (April 21, 2000)
  • K000127 — KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 (April 12, 2000)

Other clearances for product code KHJ

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • K161000 — Biodesign Otologic Repair Graft (May 11, 2016)
  • K150594 — Biodesign Otologic Repair Graft (September 16, 2015)
  • K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (September 12, 2013)
  • K121360 — BIODESIGN ENT REPAIR GRAFT (February 27, 2013)
  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIAL (June 6, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (December 9, 2008)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)

FDA data resources