Home / 510(k) Clearances / K090272

510(k) K090272

SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) by Cardinal Health, Inc. — Product Code GZT

K090272 is an FDA 510(k) premarket notification submitted by Cardinal Health, Inc. for the device "SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)". The FDA issued a decision of Substantially Equivalent on March 18, 2009. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Cardinal Health, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2009
Date Received
February 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

Other clearances by Cardinal Health, Inc.

  • K221603 — Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (December 20, 2022)
  • K211765 — Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse G (November 23, 2021)
  • K170198 — Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested f (June 15, 2017)
  • K160411 — Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating (July 25, 2016)
  • K160875 — Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with (July 11, 2016)
  • K153316 — Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coatin (May 12, 2016)
  • K122696 — POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) (January 31, 2013)
  • K121897 — PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES (July 27, 2012)
  • K120934 — PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTE (May 23, 2012)
  • K111878 — PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES (September 29, 2011)

Other clearances for product code GZT

  • K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clam (May 13, 2022)
  • K202694 — Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (January 14, 2021)
  • K202072 — MindsEye Expandable Port (August 26, 2020)
  • K180610 — Geister retractor for neuro - and spine surgery (August 29, 2018)
  • K172433 — NICO BrainPath (September 7, 2017)
  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (March 20, 2017)
  • K161004 — Self-retaining Retractor (September 9, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)

FDA data resources