Cleared Traditional

K023725 - HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247

K023725 is an FDA 510(k) clearance for HEMORRHAGE OCCLUDER PIN (HOP), manufactured by Marina Medical Instruments, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K023725 · Marina Medical Instruments, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
89d
Days
Class 2
Risk

K023725 is an FDA 510(k) clearance for the HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Marina Medical Instruments, Inc. (Alpharetta, US). The FDA issued a Cleared decision on February 3, 2003 after a review of 89 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 Marina Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K023725

510(k) Number K023725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2002
Decision Date February 03, 2003
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 206
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K023725.
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
K030653 · Power Medical Interventions, Inc. · Mar 2003
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
K030411 · Ethicon Endo-Surgery, Inc. · Mar 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K024275 · United States Surgical, A Division of Tyco Healthc · Mar 2003
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V
K022313 · Power Medical Interventions, Inc. · Dec 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · United States Surgical, A Division of Tyco Healthc · Nov 2002
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
K021701 · Power Medical Interventions, Inc. · Jun 2002