Cleared Traditional

K093649 - AESCULAP STERILCONTAINER S

K093649 is an FDA 510(k) clearance for AESCULAP STERILCONTAINER S, manufactured by Aesculap. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K093649 · Aesculap · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
167d
Days
Class 2
Risk

K093649 is an FDA 510(k) clearance for the AESCULAP STERILCONTAINER S. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 167 days - an extended review cycle.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K093649

510(k) Number K093649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2009
Decision Date May 11, 2010
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 272
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K093649.
84E SERIES SINGLE PLY WRAPPER
K102864 · Lac Mac, Ltd. · Jan 2011
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
K102783 · Hinson and Hale Medical Technologies, Inc. · Dec 2010
AESCULAP STERILCONTAINER S
K093493 · Aesculap, Inc. · Jul 2010
STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS
K090068 · Case Medical, Inc. · Feb 2010
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600
K092167 · Kimberly-Clark Corp. · Nov 2009
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
K091685 · Kimberly-Clark Corp. · Sep 2009
K093649 · AESCULAP STERILCONTAINER S
Download PDF FDA Summary Aesculap