Atlas FDA

LOCALIZATION WIRE OR MARKER - SURGICAL

FDA 510(k) clearance K935457 · decided 1994-02-17

Clearance details

K-number
K935457
Device name
LOCALIZATION WIRE OR MARKER - SURGICAL
Applicant
Bip USA, Inc.
Decision
Substantially Equivalent
Date received
1993-11-12
Decision date
1994-02-17
Days to decision
97 days
Clearance type
Traditional
Product code
GDF
Device class
1
Regulation number
878.4800
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Niagara Falls, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 (K031173)Needle Tech Products, Inc.2003-07-23
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (K950311)Global Medical Products, Ltd.1995-05-26
SURGICAL INSTRUMENT GUIDE (K950007)United States Surgical, A Division of Tyco Healthc1995-03-15
BREAST LESION LOCALIZATION NEEDLE (K945124)Promex, Inc.1994-11-22
BREAST LESION LOCALIZATION NEEDLE (K944942)Promedical , Ltd.1994-11-04
BAUER TEMNO COAXIAL NEEDLE (K935538)Bauer Medical, Inc.1994-02-22
NEEDLE-GRABBER (K923840)Guardian Angel Products, Inc.1993-07-13
THE ELEVENTH FINGER (K923835)Guardian Angel Products, Inc.1993-07-09
HORIZONTAL NEEDLE GUIDE ATTACHMENT (K925875)Bip USA, Inc.1993-04-06
BREAST LESION LOCALIZATION NEEDLE (K924270)Core Medical, Inc.1992-09-23
MICROGUIDE LESION MARKING SYSTEM (K923120)Angiodynamics, Div. E-Z-Em, Inc.1992-09-01
SIMON BREAST LESION LOCALIZATION NEEDLE (K914941)Manan Medical Products, Inc.1992-05-14

Recalls involving this device

RecordFirmDate
Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37m recall (Z-2648-2014)Bard Peripheral Vascular Inc2014-09-16