Cleared Traditional

K873391 - MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8

K873391 is the FDA 510(k) clearance for MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 by Ormed Mfg., Inc.. It is a Class 1 General & Plastic Surgery device (product code GDY) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K873391 · Ormed Mfg., Inc. · General & Plastic Surgery device
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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.

View all Ormed Mfg., Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 10
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K873391.
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599 · Stryker Corp. · Feb 1996
STERILE LAPAROTOMY SPONGES
K934971 · Medsurg Industries, Inc. · Feb 1994
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988
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
X-RAY DETECTABLE LAP SPONGES
K812651 · Procter & Gamble Mfg. Co. · Oct 1981