Cleared Traditional

K230746 - Non absorbable Surgical Polypropylene S...

K230746 is an FDA 510(k) clearance for Non absorbable Surgical Polypropylene S..., manufactured by Shandong Haidike Medical Products Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K230746 · Shandong Haidike Medical Products Co., Ltd. · General & Plastic Surgery device
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Sep 2023
Decision
181d
Days
Class 2
Risk

K230746 is an FDA 510(k) clearance for the Non absorbable Surgical Polypropylene Suture. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Shandong Haidike Medical Products Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on September 14, 2023 after a review of 181 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 Products Co., Ltd. devices

FDA 510(k) Submission Details - K230746

510(k) Number K230746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2023
Decision Date September 14, 2023
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 28
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K230746.
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