Cleared Traditional

K882021 - PRO-FECT LAPAROTOMY SPONGES

K882021 · Network Trading Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
105d
Days
-
Risk

K882021 is an FDA 510(k) clearance for the PRO-FECT LAPAROTOMY SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Network Trading Corp. (Houston, US). The FDA issued a Cleared decision on August 26, 1988 after a review of 105 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 Network Trading Corp. devices

FDA 510(k) Submission Details - K882021

510(k) Number K882021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1988
Decision Date August 26, 1988
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 K882021.
NON-STERILE, BULK GAUZE SPONGES
K890727 · Cypress Medical Products, Ltd. · Mar 1989
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
GAUZE SPONGE
K882527 · Ormed Mfg., Inc. · Jul 1988
CYLINDRICAL SPONGE
K882528 · Ormed Mfg., Inc. · Jul 1988
BUTCHER STRUNG TONSIL SPONGE
K882529 · Ormed Mfg., Inc. · Jul 1988