Cleared Traditional

K142577 - PANTHER Endo Linear Cutter Staplers wit...

K142577 is an FDA 510(k) clearance for PANTHER Endo Linear Cutter Staplers wit..., manufactured by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K142577 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
272d
Days
Class 2
Risk

K142577 is an FDA 510(k) clearance for the PANTHER Endo Linear Cutter Staplers with Single Use Loading Units. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (Beijing, CN). The FDA issued a Cleared decision on June 11, 2015 after a review of 272 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. devices

FDA 510(k) Submission Details - K142577

510(k) Number K142577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date June 11, 2015
Days to Decision 272 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 115d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 176
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K142577.
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