Cleared Traditional

K183004 - WEGO-PGA RAPID

K183004 is an FDA 510(k) clearance for WEGO-PGA RAPID, manufactured by Foosin Medical Supplies Inc., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K183004 · Foosin Medical Supplies Inc., Ltd. · General & Plastic Surgery device
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Jan 2019
Decision
90d
Days
Class 2
Risk

K183004 is an FDA 510(k) clearance for the WEGO-PGA RAPID. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Foosin Medical Supplies Inc., Ltd. (Weihai, CN). The FDA issued a Cleared decision on January 28, 2019 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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. Standard predicate reliance. 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 Foosin Medical Supplies Inc., Ltd. devices

FDA 510(k) Submission Details - K183004

510(k) Number K183004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2018
Decision Date January 28, 2019
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 121
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K183004.
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
K192580 · Ethicon, Inc. · Dec 2019
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
K183183 · Ethicon, Inc. · Jun 2019
WEGO-PGLA RAPID
K183001 · Foosin Medical Supplies Inc., Ltd. · Jan 2019
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
K181652 · Ethicon, Inc. · Sep 2018
Caprolon
K181320 · Resorba Medical GmbH · Sep 2018
Rondek PGA Suture (Beige or Violet)
K180625 · Rk Manufacturing Corporation · May 2018