Cleared Traditional

K050256 - APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

K050256 is an FDA 510(k) clearance for APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR, manufactured by Apple Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K050256 · Apple Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
82d
Days
Class 1
Risk

K050256 is an FDA 510(k) clearance for the APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Apple Medical Corp. (Boston, US). The FDA issued a Cleared decision on April 26, 2005 after a review of 82 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 Apple Medical Corp. devices

FDA 510(k) Submission Details - K050256

510(k) Number K050256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2005
Decision Date April 26, 2005
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

Product Code GAD Retractor
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 - GAD Retractor

All 47
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K050256.
OTELO LL
K151104 · Spineart · Jan 2016
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · Medtronic, Inc. · Oct 2013
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
LUNG RETRACTORS: DAVIDSON, SEMB
K930316 · Thomasville Medical Assoc. · Feb 1994
THOROCOSCOPY SELF-RETAINING RETRACTOR
K926585 · T. Korossurgical Instruments Corp. · Aug 1993
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992