Cleared Traditional

K103470 - PANTHER GROUP OF SURGICAL INCLUDES: OAN...

Also marketed or referenced as:
PANTHER HEMORRHOIDAL CIRCULAR STAPLER PANTHER LINEAR STAP

K103470 is an FDA 510(k) clearance for PANTHER GROUP OF SURGICAL INCLUDES: OAN..., 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 46-day FDA review.

K103470 · 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
Jan 2011
Decision
46d
Days
Class 2
Risk

K103470 is an FDA 510(k) clearance for the PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER. 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 January 11, 2011 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. devices

FDA 510(k) Submission Details - K103470

510(k) Number K103470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2010
Decision Date January 11, 2011
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
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
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