LOCALIZATION WIRE OR MARKER - SURGICAL— 510(k) K935457

Name: FDA 510(k) clearance K935457
Creator: U.S. Food and Drug Administration
Published: 1994-02-17

Substantially Equivalent

Bip USA, Inc.

FDA 510(k) clearance K935457 for LOCALIZATION WIRE OR MARKER - SURGICAL, Substantially Equivalent on 1994-02-17. Applicant: Bip USA, Inc.. Device class: 1.

Clearance details

Applicant: Bip USA, Inc.
Product code: Code GDF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1993-11-12
Decision date: 1994-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niagara Falls, NY, US

Download summary PDF View on FDA.gov ↗

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K934370 — BIP BIOPSY NEEDLE MODIFICATION1994-03-07
K925870 — SPACER1993-05-19
K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT1993-04-06

Recalls naming K935457

K-number listed on FDA's recall record

Z-2648-2014 — Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.Class II·Terminated·Bard Peripheral Vascular Inc·20140826

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K935457.

Data sourced from openFDA. This site is unofficial and independent of the FDA.