Cleared Traditional

K831914 - STRUNG NEURO SPONGE PATTIES-X-RAY-

K831914 is an FDA 510(k) clearance for STRUNG NEURO SPONGE PATTIES-X-RAY-, manufactured by Ormed Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K831914 · Ormed Mfg., Inc. · General & Plastic Surgery device
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Oct 1983
Decision
139d
Days
Class 1
Risk

K831914 is an FDA 510(k) clearance for the STRUNG NEURO SPONGE PATTIES-X-RAY-. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Ormed Mfg., Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 139 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 Ormed Mfg., Inc. devices

FDA 510(k) Submission Details - K831914

510(k) Number K831914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date October 31, 1983
Days to Decision 139 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
24d slower than avg
Panel avg: 115d · This submission: 139d
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 K831914.
GAUZE & LAB SPONGES STERILE & NON
K842572 · Ulti-Med Intl., Inc. · Aug 1984
NEURO SPONGE
K840541 · Surgicot, Inc. · Apr 1984
FLORET FOAM PREP SPONGE
K833626 · Ritmed, Inc. · Feb 1984
COLOR-EZE PRE-WASHED LAP SPONGES
K831913 · Ormed Mfg., Inc. · Sep 1983
FLORET VAGINAL PACKING/TAMPONS
K830260 · Ritmed, Inc. · Mar 1983
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · American Medical Disposable, Inc. · Feb 1983