Cleared Traditional

K830260 - FLORET VAGINAL PACKING/TAMPONS

K830260 is an FDA 510(k) clearance for FLORET VAGINAL PACKING/TAMPONS, 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 51-day FDA review.

K830260 · Ritmed, Inc. · General & Plastic Surgery device
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Mar 1983
Decision
51d
Days
Class 1
Risk

K830260 is an FDA 510(k) clearance for the FLORET VAGINAL PACKING/TAMPONS. 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 March 17, 1983 after a review of 51 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 Ritmed, Inc. devices

FDA 510(k) Submission Details - K830260

510(k) Number K830260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date March 17, 1983
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
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 K830260.
FLORET FOAM PREP SPONGE
K833626 · Ritmed, Inc. · Feb 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
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · American Medical Disposable, Inc. · Feb 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202 · American Medical Disposable, Inc. · Feb 1983
PARKE-DAVIS AEGIS ABOSRBENT SPONGES
K813595 · Deseret Medical, Inc. · Jan 1982