Retractor, Self-Retaining, For Neurosurgery
Regulation 882.4800
1510(k)s in 12 months (44 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in GZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Nico Corporation | 3 | 3 |
| Ohio Medical Instrument Co., Inc. | 2 | 1 |
| Vycor Medical, Inc. | 2 | 1 |
| Johnson & Johnson | 2 | 0 |
| Medical Equipment Development Co., Inc. | 2 | 0 |
| T. Korossurgical Instruments Corp. | 2 | 0 |
| A. Henniss | 1 | 0 |
| Abbott Spine | 0 | 1 |
| Baxter Healthcare Corp | 1 | 0 |
| Bright Medical Instruments | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2018 | Nico Corp. NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device
Part Number: NN-8024 Terminated |
GZT | None listed |
| Jan 17, 2013 | Vycor Medical, Inc. Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***
Product Usage:
The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor s Terminated |
GZT | K060973 |
| Aug 13, 2012 | Nico Corp. 13.5 mm x 60 mm BrainPath Sheath
The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sh Terminated |
GZT | K120691 |
| Aug 13, 2012 | Nico Corp. 13.5 mm x 50 mm BrainPath Sheath
The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sh Terminated |
GZT | K120691 |
| Feb 13, 2008 | Abbott Spine Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Har Terminated |
GZT | K050706 |
| Apr 25, 2003 | Ohio Medical Instrument Co Inc Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part Terminated |
GZT | K830332 |
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