Cleared Traditional

K884790 - QUALTEX NEUROLOK SURGICAL SPONGE

K884790 is an FDA 510(k) clearance for QUALTEX NEUROLOK SURGICAL SPONGE, manufactured by Deroyal Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K884790 · Deroyal Industries, Inc. · General & Plastic Surgery device
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Dec 1988
Decision
24d
Days
Class 1
Risk

K884790 is an FDA 510(k) clearance for the QUALTEX NEUROLOK SURGICAL SPONGE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 24 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.

FDA 510(k) Submission Details - K884790

510(k) Number K884790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1988
Decision Date December 09, 1988
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 110
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K884790.
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358 · Advance Medical Designs, Inc. · Nov 1990
X-RAY DETECTABLE GAUZE SPONGE
K895372 · Keilei Intl., Inc. · Nov 1989
MASCOT LAB SPONGE
K894984 · Mascot, Inc. · Sep 1989
GAUZE PACKING, X-RAY DETECTABLE
K882707 · Bioseal · Aug 1988
GAUZE SPONGE, X-RAY DETECTABLE
K882708 · Bioseal · Aug 1988
TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
K882709 · Bioseal · Aug 1988
K884790 · QUALTEX NEUROLOK SURGICAL SPONGE
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