Home / 510(k) Clearances / K935529

510(k) K935529

CERVICAL SELF-RETAINING RETRACTOR by T. Korossurgical Instruments Corp. — Product Code GZT

K935529 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "CERVICAL SELF-RETAINING RETRACTOR". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1994
Date Received
November 16, 1993
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 T. Korossurgical Instruments Corp.

  • K001915 — GRAFT MARKER RING (April 27, 2001)
  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K954016 — VIDEOSCOPE W/IRRIGATION SHEATH (January 25, 1996)
  • K953998 — DISCETOME TISSUE ASPIRATOR (December 4, 1995)
  • K954052 — ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (November 6, 1995)
  • K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (November 6, 1995)
  • K926583 — REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR (August 6, 1993)
  • K926585 — THOROCOSCOPY SELF-RETAINING RETRACTOR (August 6, 1993)
  • K931262 — REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR (August 6, 1993)
  • K931259 — ENDOSCOPIC OR THORASCOPIC FORCEPS (June 8, 1993)

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