510(k) K082010
- Device
- STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
- Applicant
- STRYKER IRELAND LTD., INSTRUMENTS DIVISION
- 510(k) number
- K082010
- Product code
- HBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-29
- Date received
- 2008-07-15
- Regulation
- 882.4305
- Classification name
- Drills, Burrs, Trephines & Accessories (compound, Powered)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLETTE O'CONNOR
- Address
- Carrigtwohill Business & Technology Park Carrigtwohill, Co.Cork IE
FDA Registration Numbers#
- 3040335671
- 3009732568
- 3015967359
- 3010173425
- 9616696
- 3003418325
- 1058584
- 1220477
- 3030733800
- 3014334038
- 3010370650
- 3010726901
- 1045834
- 3009417901
- 3014579161
- 3010155648
- 3007031059
- 3005562917
- 2030624
- 1828288
- 3012494290
- 1220724
- 3012421607
- 3010596852
- 3013557562
- 1526534
- 3010097171
Source Documents#
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 |
| 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 |
| K875019 | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | Neurodynamics, Inc. | 1988-01-22 |
| K833266 | ACRA-CUT | Acra Cut, Inc. | 1983-12-29 |
Legacy Summary#
summary
FDA Review#
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