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510(k) K874956

SELF-RETAINING RETRACTOR FOR NEUROSURGERY by Solway, Inc. — Product Code GZT

K874956 is an FDA 510(k) premarket notification submitted by Solway, Inc. for the device "SELF-RETAINING RETRACTOR FOR NEUROSURGERY". The FDA issued a decision of Substantially Equivalent on January 28, 1988. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Solway, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1988
Date Received
December 2, 1987
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 Solway, Inc.

  • K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS (February 5, 1988)
  • K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (February 2, 1988)
  • K874964 — DENTAL HAND INSTRUMENTS (January 27, 1988)
  • K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS) (January 22, 1988)
  • K874966 — TUNING FORKS (January 4, 1988)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874961 — BONE CUTTING INSTRUMENTS & ACCESSORIES (December 30, 1987)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K874952 — MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES (December 30, 1987)

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