Cleared Traditional

K252532 - Inno-Port Disposable Bladed Trocar

K252532 is an FDA 510(k) clearance for Inno-Port Disposable Bladed Trocar, manufactured by Taiwan Surgical Corporation. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K252532 · Taiwan Surgical Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
294d
Days
Class 2
Risk

K252532 is an FDA 510(k) clearance for the Inno-Port Disposable Bladed Trocar. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Taiwan Surgical Corporation (Zhubei City, TW). The FDA issued a Cleared decision on June 2, 2026 after a review of 294 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Taiwan Surgical Corporation devices

FDA 510(k) Submission Details - K252532

510(k) Number K252532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2025
Decision Date June 02, 2026
Days to Decision 294 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
179d slower than avg
Panel avg: 115d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 1047
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K252532.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
K260710 · FloShield, Inc. · Jun 2026
“Tech-Image” Video Endoscope System
K260414 · Tech-Image CO., LTD. · Jun 2026
TroKit Laparoscope Lens Wiper
K253994 · TroCare, LLC · Jun 2026
4K NIR/ICG Imaging System
K260318 · Zhejiang Healnoc Technology Co., Ltd. · May 2026
MediBot Needle Driver Uno
K260183 · Parallel Robotics, LLC · May 2026
Laport
K252985 · Sejong Medical Co., Ltd. · May 2026