Cleared Traditional

K945553 - ROUND STICK SPONGES

K945553 is an FDA 510(k) clearance for ROUND STICK SPONGES, manufactured by Lorrex Health Products. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K945553 · Lorrex Health Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Dec 1994
Decision
48d
Days
Class 1
Risk

K945553 is an FDA 510(k) clearance for the ROUND STICK SPONGES, FLAT STICK SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Lorrex Health Products (Secaucus, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4450 - 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 Lorrex Health Products devices

FDA 510(k) Submission Details - K945553

510(k) Number K945553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1994
Decision Date December 28, 1994
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

Product Code GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDY Gauze/sponge, Internal, X-ray Detectable

All 38
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K945553.
ULTRACELL ORTHOPEDIC SPONGES
K950372 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL ORTHOPEDIC SPONGES
K950373 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL RETRACTOR COVERS
K950659 · Ultracell Medical Technologies, Inc. · Apr 1995
OREX
K940764 · Thantex Specialties, Inc. · Dec 1994
OREX (18X18 X-RAY DETECTABLE)
K940766 · Thantex Specialties, Inc. · Dec 1994
OREX (12X12 X-RAY DETECTABLE)
K940767 · Thantex Specialties, Inc. · Dec 1994