Cleared Traditional

K790631 - STERAID SURGICAL DRESSING

K790631 · Corda Intl. Holdings, Inc. · General & Plastic Surgery device
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Jul 1979
Decision
118d
Days
-
Risk

K790631 is an FDA 510(k) clearance for the STERAID SURGICAL DRESSING. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Corda Intl. Holdings, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Corda Intl. Holdings, Inc. devices

FDA 510(k) Submission Details - K790631

510(k) Number K790631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1979
Decision Date July 30, 1979
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K790631.
TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER
K792617 · American Medical Disposable, Inc. · Jan 1980
TRACHEOTOMY SPONGE, NON-WOVEN DELNET
K792618 · American Medical Disposable, Inc. · Jan 1980
VAGINAL PACKING
K792431 · American Medical Disposable, Inc. · Dec 1979
BURN PAD, DRY, STERILE
K781985 · Chesebrough-Pond'S U.S.A. Co. · Dec 1978
SPECIALTY SPONGES
K781420 · Ipco Corp. · Oct 1978
LAPOROTOMY SPONGE
K780806 · Abco Dealers, Inc. · Jun 1978