Cleared Traditional

K232355 - Non absorbable Surgical Silk Suture (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232355 · Shandong Haidike Medical Product Co., Ltd. · General & Plastic Surgery device
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Jan 2024
Decision
162d
Days
Class 2
Risk

K232355 is an FDA 510(k) clearance for the Non absorbable Surgical Silk Suture. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Shandong Haidike Medical Product Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on January 16, 2024 after a review of 162 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - 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 Shandong Haidike Medical Product Co., Ltd. devices

Submission Details

510(k) Number K232355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2023
Decision Date January 16, 2024
Days to Decision 162 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
48d slower than avg
Panel avg: 114d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 Peers - GAP Suture, Nonabsorbable, Silk

All 40
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K232355.
Sofsilk™ Coated Braided Silk Suture
K241486 · Covidien · Dec 2024
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
K222944 · Safepath Medical, Inc. · Oct 2024
Surgical Sutures with or without Needle
K221767 · Huaian Seamen Medical Technology Co., Ltd. · Jul 2023