Cleared Traditional

K936226 - SURGIMED BREAST LOCALIZATION NEEDLE WIR...

K936226 is the FDA 510(k) clearance for SURGIMED BREAST LOCALIZATION NEEDLE WIR... by Meadox Medicals, Div. Boston Scientific Corp.. It is a Class 1 General & Plastic Surgery device (product code KDC) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K936226 · Meadox Medicals, Div. Boston Scientific Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
68d
Days
Class 1
Risk

K936226 is an FDA 510(k) clearance for the SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 68 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K936226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date March 07, 1994
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDC Instrument, Surgical, Disposable
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 - KDC Instrument, Surgical, Disposable

All 23
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K936226.
INSTRUMENT ORGANIZER
K914960 · O.R. Concepts, Inc. · Feb 1992
BRADLEY TENACULUM HOLDER
K903649 · Marlo Surgical Technology · Nov 1990
RICHARD-ALLAN VESSEL LOOPS
K900566 · Richard-Allan Medical Ind., Inc. · May 1990
INSTRUMENT MAKAR DISPOSALBE LOOP
K853597 · Instrument Makar, Inc. · Sep 1985
MICRO-EDGE DISPOSABLE BLADES
K832680 · Micromedics, Inc. · Oct 1983
C-LOOPS
K830800 · Concept, Inc. · Oct 1983