Cleared Traditional

K833626 - FLORET FOAM PREP SPONGE

K833626 is an FDA 510(k) clearance for FLORET FOAM PREP SPONGE, manufactured by Ritmed, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K833626 · Ritmed, Inc. · General & Plastic Surgery device
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Feb 1984
Decision
126d
Days
Class 1
Risk

K833626 is an FDA 510(k) clearance for the FLORET FOAM PREP SPONGE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Ritmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984 after a review of 126 days - within the typical 510(k) review window.

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: 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 Ritmed, Inc. devices

FDA 510(k) Submission Details - K833626

510(k) Number K833626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date February 17, 1984
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
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 57
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K833626.
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
K863089 · Lifestream Int'L, Inc. · Oct 1986
GAUZE & LAB SPONGES STERILE & NON
K842572 · Ulti-Med Intl., Inc. · Aug 1984
NEURO SPONGE
K840541 · Surgicot, Inc. · Apr 1984
STRUNG NEURO SPONGE PATTIES-X-RAY-
K831914 · Ormed Mfg., Inc. · Oct 1983
COLOR-EZE PRE-WASHED LAP SPONGES
K831913 · Ormed Mfg., Inc. · Sep 1983
FLORET VAGINAL PACKING/TAMPONS
K830260 · Ritmed, Inc. · Mar 1983