510(k) K060097
- Device
- GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
- Applicant
- KLS-MARTIN L.P.
- 510(k) number
- K060097
- Product code
- GZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-02-27
- Date received
- 2006-01-13
- Regulation
- 882.4800
- Classification name
- Retractor, Self-retaining, For Neurosurgery
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER DAMATO
- Address
- 11239 St. Johns Industrial Pkwy. S. Jacksonville FL US 32246 32246
FDA Registration Numbers#
- 1222616
- 1218882
- 3011743372
- 2029275
- 9610612
- 1835444
- 3008110533
- 3007456622
- 3010202439
- 3011547624
- 1421101
- 3004608878
- 8010422
- 3008868758
- 2183671
- 1064858
- 9680242
- 8043792
- 1057425
- 1526439
- 9710524
- 1220477
- 1923569
- 1528646
- 9611274
- 9611112
- 3005180920
- 3000270450
- 3005880844
- 2424366
- 2183946
- 3015831087
- 8030607
- 2020550
- 8010697
- 3042638647
- 3015967359
- 3003418325
- 1836161
- 2134285
- 3006554912
- 3004513872
- 1834379
- 1450428
- 3004215117
- 2916714
- 3003322138
- 1834331
- 3005528784
- 3008864603
- 1417592
- 3005726885
- 3012995405
- 8010303
- 3008770252
- 3008114965
- 1056350
- 2031093
- 8010099
- 3008837339
- 1219659
- 2133810
- 8010665
- 8040233
- 2032098
- 3010041511
- 1526531
- 3004464325
- 1221763
- 2133928
- 1225838
- 1421879
- 3007507973
- 3013505638
- 1424478
- 3010687973
- 3007648354
- 3011137372
- 9680519
- 3009420598
Source Documents#
Other 510(k) Records For Product Code GZT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | Thompson Surgical Instruments, Inc. | 2022-05-13 |
| K202694 | Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) | Vycor Medical, Inc. | 2021-01-14 |
| K202072 | MindsEye Expandable Port | Minnetronix Neuro, Inc. | 2020-08-26 |
| K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | 2018-08-29 |
| K172433 | NICO BrainPath | Nico Corporation | 2017-09-07 |
| K161680 | MEDICON Spinal Spreading Systems | Medicon EG | 2017-03-24 |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | Tedan Surgical Innovations, LLC | 2017-03-20 |
| K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016-09-09 |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Nico Corporation | 2015-06-12 |
| K120691 | BRAIN PORT | Nico Corporation | 2012-06-05 |
| K113273 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | 2012-01-27 |
| K112913 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | 2011-12-16 |
| K093054 | SCALP DURA RETRACTOR, MODEL KS00474 | KARL STORZ Endoscopy-America, Inc. | 2010-11-15 |
| K090272 | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | Cardinal Health, Inc. | 2009-03-18 |
| K071771 | INSTRUMED RETRACTORS | Instrumed International, Inc. | 2007-08-02 |
Legacy Summary#
summary
FDA Review#
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