Atlas FDA

GZT

43 FDA 510(k) clearances · Product code

55 daysmedian time to decision
313 days90th percentile
43clearances measured

FDA profile

Official device name
Retractor, Self-Retaining, For Neurosurgery
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4800
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2004: 5 · 2006: 2 · 2010: 4 · 2012: 6 · 2013: 12 · 2014: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) (K210615)Thompson Surgical Instruments, Inc.2022-05-13
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) (K202694)Vycor Medical, Inc.2021-01-14
MindsEye Expandable Port (K202072)Minnetronix Neuro, Inc.2020-08-26
Geister retractor for neuro - and spine surgery (K180610)Geister Medizin Technik GmbH2018-08-29
NICO BrainPath (K172433)Nico Corporation2017-09-07
MEDICON Spinal Spreading Systems (K161680)Medicon EG2017-03-24
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems (K161318)Tedan Surgical Innovations, LLC2017-03-20
Self-retaining Retractor (K161004)Fetzer Medical GmbH & Co. KG2016-09-09
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (K150378)Nico Corporation2015-06-12
BRAIN PORT (K120691)Nico Corporation2012-06-05
SPOTLIGHT ACCESS SYSTEM (K113273)Johnson & Johnson2012-01-27
SPOTLIGHT ACCESS SYSTEM (K112913)Johnson & Johnson2011-12-16
SCALP DURA RETRACTOR, MODEL KS00474 (K093054)KARL STORZ Endoscopy-America, Inc.2010-11-15
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) (K090272)Cardinal Health, Inc.2009-03-18
INSTRUMED RETRACTORS (K071771)Instrumed International, Inc.2007-08-02
FLEX ARM RETRACTOR SYSTEM (K071338)Koros USA, Inc.2007-05-29
PIPELINE II ACCESS SYSTEM (K062814)Depuy Spine, Inc.2006-12-15
VYCOR SURGICAL ACCESS SYSTEMS (K060973)Vycor Medical, LLC2006-07-26
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 (K060097)KLS-Martin L.P.2006-02-27
HARMONY PORT SYSTEM, MODEL 1907 SERIES (K050706)Spinal Concepts, Inc.2005-04-15
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM (K992898)Bright Medical Instruments1999-10-21
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM (K964402)V. Mueller Neuro/Spine1997-01-23
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 (K960807)Ohio Medical Instrument Co., Inc.1996-05-17
HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR (K945040)Hamid M. Mehdizadeh, M.D.1995-01-13
CERVICAL SELF-RETAINING RETRACTOR (K935529)T. Korossurgical Instruments Corp.1994-03-22
TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED (K924876)Graham-Field, Inc.1994-03-01
CODMAN LHALO SPLIT RING RETRACTOR SYSTEM (K913233)Codman & Shurtleff, Inc.1991-07-31
BLADES FOR SPINAL LAMINECTOMY RETRACTOR (K910621)International Hospital Supply Co.1991-04-01
ADSON-BECKMAN RETRACTOR, SPINAL (K905445)A. Henniss1991-01-25
NEUROSURGICAL HEADFRAME ACCESSORIES (K902517)Sims Surgical, Inc.1990-07-03
ESI MODEL MS-103 (K885120)Electrical Systems Div.1990-01-19
COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM (K896156)Stereotactic Medical Systems, Inc.1989-12-06
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR (K895395)Baxter Healthcare Corp1989-10-19
MODIFIED MEMORY RETRACTOR ARM (K895537)Medical Equipment Development Co., Inc.1989-09-22
NEUROSURICAL RETRACTORS - VARIOUS TYPES (K892543)Zinnanti Surgical Instruments, Inc.1989-05-05
CRANK FRAME RETRACTOR (K882071)Karlin Technology, Inc.1988-06-10
CRANK FRAME RETRACTOR (K881160)T. Korossurgical Instruments Corp.1988-04-06
MEDCO MEMORY RETRACTOR SYSTEM (K874829)Medical Equipment Development Co., Inc.1988-03-24
SELF-RETAINING RETRACTOR FOR NEUROSURGERY (K874956)Solway, Inc.1988-01-28
CEDAR(TM) RETRACTOR RING (K873691)Cedar Surgical, Inc.1987-09-28
BUDDE-HALO RETRACTOR (K830332)Ohio Medical Instrument Co., Inc.1983-03-02
CYCLOPAC TENS (K801855)Dow Corning Wright1980-08-13
DISPOSABLE SKIN RETRACTOR (K801151)Cimarron Instruments, Inc.1980-05-20

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Every clearance here is in the API, with alerts when new ones post.