510(k) K875019
- Device
- GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
- Applicant
- NEURODYNAMICS, INC.
- 510(k) number
- K875019
- Product code
- HBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-22
- Date received
- 1987-12-04
- Regulation
- 882.4305
- Classification name
- Drills, Burrs, Trephines & Accessories (compound, Powered)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARGARET R MEADE
- Address
- P.O. Box 603, Lenox Hill Station New York NY US 10021 10021
FDA Registration Numbers#
- 3014334038
- 1058584
- 3010370650
- 3009732568
- 3013557562
- 3015967359
- 3010596852
- 3010097171
- 3014579161
- 3007031059
- 3005562917
- 3010726901
- 9616696
- 1220724
- 3009417901
- 3012421607
- 1220477
- 3010155648
- 3010173425
- 2030624
- 1045834
- 1526534
- 3012494290
- 3014724561
- 3003418325
- 3030733800
- 3040335671
- 1828288
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024-03-06 |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 2022-06-20 |
| K183581 | Codman Disposable Perforators | Integra Lifesciences Corp. | 2019-01-20 |
| K141455 | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | Micromar Ind. Com. , Ltd. | 2015-03-16 |
| K121253 | MERIDIAN CRANIAL PERFORATOR | Adeor Medical Technologies GmbH | 2012-07-17 |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | 2008-12-29 |
| K082637 | CRANIAL PERFORATOR | The Anspach Effort, Inc. | 2008-12-22 |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Codman & Shurtleff, Inc. | 2008-01-04 |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007-10-22 |
| K032970 | ACRA-CUT XPRESS 120 | Acra Cut, Inc. | 2003-12-08 |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | The Anspach Effort, Inc. | 1998-10-21 |
| K933894 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-12-10 |
| K924242 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-07-08 |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | Acra Cut, Inc. | 1989-06-15 |
| K833266 | ACRA-CUT | Acra Cut, Inc. | 1983-12-29 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases