Cleared Traditional

K201639 - Disposable Circular Staple

K201639 is an FDA 510(k) clearance for Disposable Circular Staple, manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K201639 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2021
Decision
345d
Days
Class 2
Risk

K201639 is an FDA 510(k) clearance for the Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linea.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 27, 2021 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Beijing Biosis Healing Biolog Ical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K201639

510(k) Number K201639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2020
Decision Date May 27, 2021
Days to Decision 345 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 115d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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.

Regulatory Peers - GDW Staple, Implantable

All 161
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K201639.
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