Cleared Traditional

K202994 - InnoClip Disposable Clip Applier, InnoClip Clip Applier (FDA 510(k) Clearance)

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

K202994 · Taiwan Surgical Corporation · General & Plastic Surgery device
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Jan 2022
Decision
460d
Days
Class 2
Risk

K202994 is an FDA 510(k) clearance for the InnoClip Disposable Clip Applier, InnoClip Clip Applier. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Taiwan Surgical Corporation (Zhubei City, TW). The FDA issued a Cleared decision on January 4, 2022 after a review of 460 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 878.4300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Taiwan Surgical Corporation devices

Submission Details

510(k) Number K202994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2020
Decision Date January 04, 2022
Days to Decision 460 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
346d slower than avg
Panel avg: 114d · This submission: 460d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 175
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K202994.
InnoClip Clip Applier
K253781 · Taiwan Surgical Corporation · Dec 2025
InnoClip Disposable Clip Applier
K253903 · Taiwan Surgical Corporation · Dec 2025
Disposable Polymer Ligation Clips
K250643 · Hangzhou Kangji Medical Instrument Co., Ltd. · Nov 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
K251054 · Teleflex Medical · Jul 2025
GEM ZIPCLIP
K242541 · Synovis Micro Companies Alliance A Subsidiary of Baxter Int · Jan 2025
SOLID CLIP™ Single Use Clip Applier
K221495 · Medscope Biotech Co., Ltd. · Jul 2024