Cleared Traditional

K012105 - POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM

K012105 is an FDA 510(k) clearance for POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM, manufactured by Symmetry Medical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K012105 · Symmetry Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
393d
Days
Class 2
Risk

K012105 is an FDA 510(k) clearance for the POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Symmetry Medical, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 2, 2002 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Symmetry Medical, Inc. devices

FDA 510(k) Submission Details - K012105

510(k) Number K012105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2001
Decision Date August 02, 2002
Days to Decision 393 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 129d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 225
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K012105.
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
K050570 · Miltex, Inc. · Jul 2005
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
K042062 · Bard Peripheral Vascular, Inc. · Sep 2004
OLYMPUS STERILIZATION TRAYS
K033222 · Olympus Winter & Ibe GmbH · Aug 2004
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
K993764 · Medipack Medical Packaging Mfg. Co. · Dec 1999
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · Medicel, S.A. DE C.V. · Feb 1999
C/T MED-SYSTEMS CASSETTE SYSTEM
K980065 · C/T Med System, Ltd. · May 1998