Cleared Traditional

K781818 - LAPARATOMY SPONGE

K781818 is an FDA 510(k) clearance for LAPARATOMY SPONGE, manufactured by Meden Medical Sales Division. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K781818 · Meden Medical Sales Division · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1978
Decision
19d
Days
Class 1
Risk

K781818 is an FDA 510(k) clearance for the LAPARATOMY SPONGE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Meden Medical Sales Division (Mchenry, US). The FDA issued a Cleared decision on November 15, 1978 after a review of 19 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 Meden Medical Sales Division devices

FDA 510(k) Submission Details - K781818

510(k) Number K781818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1978
Decision Date November 15, 1978
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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 58
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K781818.
CONTAIN X-RAY DETECTABLE LAP SPONGE
K801768 · The Buckeye Cellulose Corp. · Aug 1980
STERILIZATION PROCESS/X-RAY DETECT. SPG
K792630 · Procter & Gamble Mfg. Co. · Jan 1980
LAP SPONGE
K782107 · Carapace, Inc. · Feb 1979
SOF-WICKLAP PAD
K780718 · Johnson & Johnson Professionals, Inc. · Jun 1978
ARTERIAL LINE KIT
K780871 · Argon Medical Corp. · Jun 1978
LAPAROTOMY SPONGES, STERILE
K771395 · Medline Industries, Inc. · Aug 1977