Atlas FDA

GHAJAR GUIDE SYSTEM FOR THE PERFORATOR

FDA 510(k) clearance K875019 · decided 1988-01-22

Clearance details

K-number
K875019
Device name
GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
Applicant
Neurodynamics, Inc.
Decision
Substantially Equivalent
Date received
1987-12-04
Decision date
1988-01-22
Days to decision
49 days
Clearance type
Traditional
Product code
HBF
Device class
2
Regulation number
882.4305
Medical specialty
Neurology
Advisory committee
Neurology
Location
New York, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Neurodynamics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
evoDrill Cranial Perforator (K231403)Evonos GmbH & Co. KG2024-03-06
NeuroLine Disposable Cranial Perforator with Hudson end (K213228)Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.2022-06-20
Codman Disposable Perforators (K183581)Integra Lifesciences Corp.2019-01-20
EASYDRILL AUTOSTOP CRANIAL PERFORATOR (K141455)Micromar Ind. Com. , Ltd.2015-03-16
MERIDIAN CRANIAL PERFORATOR (K121253)Adeor Medical Technologies GmbH2012-07-17
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT (K082010)Stryker Ireland Ltd., Instruments Division2008-12-29
CRANIAL PERFORATOR (K082637)The Anspach Effort, Inc.2008-12-22
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 (K073336)Codman & Shurtleff, Inc.2008-01-04
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 (K071931)Codman & Shurtleff, Inc.2007-10-22
ACRA-CUT XPRESS 120 (K032970)Acra Cut, Inc.2003-12-08
ANSPACH ACCESS CRANIAL PERFORATOR (K982991)The Anspach Effort, Inc.1998-10-21
DISPOSABLE PERFORATOR (K933894)Codman & Shurtleff, Inc.1993-12-10

Recalls involving this device

No recalls on record reference this clearance.