Cleared Traditional

K935457 - LOCALIZATION WIRE OR MARKER - SURGICAL

K935457 is an FDA 510(k) clearance for LOCALIZATION WIRE OR MARKER - SURGICAL, manufactured by Bip USA, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K935457 · Bip USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
97d
Days
Class 1
Risk

K935457 is an FDA 510(k) clearance for the LOCALIZATION WIRE OR MARKER - SURGICAL. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Bip USA, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bip USA, Inc. devices

FDA 510(k) Submission Details - K935457

510(k) Number K935457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1993
Decision Date February 17, 1994
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

GDF Device Classification - Class 1, General Controls

Product Code GDF Guide, Needle, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDF Guide, Needle, Surgical

All 15
Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K935457.
SURGICAL INSTRUMENT GUIDE
K950007 · United States Surgical, A Division of Tyco Healthc · Mar 1995
SIMON BREAST LESION LOCALIZATION NEEDLE
K914941 · Manan Medical Products, Inc. · May 1992
PERCUGUIDE LESION MARKING
K920816 · E-Z-Em, Inc. · Apr 1992
ACCUPLACE (TM)
K904172 · Dlp, Inc. · Nov 1990
MICROSURGICAL NEEDLE HOLDERS
K890211 · Kinetic Medical Products · Jan 1989
SURGICAL NEEDLE GUIDE
K890228 · Kinetic Medical Products · Jan 1989