Cleared Traditional

K200335 - Sterisheet Sterilization Wrap

K200335 is an FDA 510(k) clearance for Sterisheet Sterilization Wrap, manufactured by Andersen Sterilizers, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K200335 · Andersen Sterilizers, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
275d
Days
Class 2
Risk

K200335 is an FDA 510(k) clearance for the Sterisheet Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on November 12, 2020 after a review of 275 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.

View all Andersen Sterilizers, Inc. devices

FDA 510(k) Submission Details - K200335

510(k) Number K200335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2020
Decision Date November 12, 2020
Days to Decision 275 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 129d · This submission: 275d
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 149
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K200335.
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Tyvek Sterilization Pouches with Chevron Seal
K200336 · Andersen Sterilizers, Inc. · Nov 2020
Turbett Instrument Pod
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K193561 · Weihai Xingtai Packaging Products Co., Ltd. · Apr 2020