Cleared Special

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (K193561) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K193561 · Weihai Xingtai Packaging Products Co., Ltd. · General Hospital
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Apr 2020
Decision
114d
Days
Class 2
Risk

K193561 is an FDA 510(k) clearance for the Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical De.... Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Weihai Xingtai Packaging Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on April 15, 2020 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Weihai Xingtai Packaging Products Co., Ltd. devices

Submission Details

510(k) Number K193561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date April 15, 2020
Days to Decision 114 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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