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510(k) K011115

KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 by Heinz Kurz GmbH Medizintechnik — Product Code MML

K011115 is an FDA 510(k) premarket notification submitted by Heinz Kurz GmbH Medizintechnik for the device "KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010". The FDA issued a decision of Substantially Equivalent on May 2, 2001. The device falls under product code MML (Weights, Eyelid, External), a Class II device regulated under 21 CFR 886.5700. Heinz Kurz GmbH Medizintechnik has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2001
Date Received
April 12, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Weights, Eyelid, External
Device Class
Class II
Regulation Number
886.5700
Review Panel
OP
Submission Type

Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)

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)
  • K033796 — KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS (January 30, 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)
  • 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 MML

  • K170591 — Altomed Malhotra Platinum Segments (June 6, 2017)
  • K150986 — Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants (August 17, 2015)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K011740 — CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) (July 2, 2001)
  • K003646 — SUTUREGROOVE WEIGHT SIZING SET (February 22, 2001)
  • K001123 — KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 (April 21, 2000)
  • K994289 — SUTUREGROOVE (April 17, 2000)
  • K000127 — KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 (April 12, 2000)
  • K990224 — LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET (April 12, 1999)
  • K983607 — LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS (January 8, 1999)

FDA data resources