Cleared Traditional

K873391 - MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8

K873391 is an FDA 510(k) clearance for MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8, 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 18-day FDA review.

K873391 · Ormed Mfg., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
18d
Days
Class 1
Risk

K873391 is an FDA 510(k) clearance for the MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on September 11, 1987 after a review of 18 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 - K873391

510(k) Number K873391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date September 11, 1987
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 K873391.
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
NON-WOVEN TRACHEOTOMY SPONGE
K872807 · American Silk Sutures, Inc. · Aug 1987
GAUZE CHERRY SPONGE
K872809 · American Silk Sutures, Inc. · Aug 1987
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
K864529 · Elof Hansson, Inc. · Dec 1986
K873391 · MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
Download PDF Ormed Mfg., Inc.