Cleared Traditional

K963134 - DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)

K963134 · Igenics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
25d
Days
-
Risk

K963134 is an FDA 510(k) clearance for the DRAIN/SLIT SPONGE (NON-STERILE AND STERILE). Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Igenics, Inc. (Boston, US). The FDA issued a Cleared decision on September 6, 1996 after a review of 25 days - a notably fast clearance cycle.

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: 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 Igenics, Inc. devices

FDA 510(k) Submission Details - K963134

510(k) Number K963134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date September 06, 1996
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K963134.
GAUZE COMPRESS
K960615 · Certified Safety Mfg., Inc. · Nov 1996
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963188 · Codi International BV · Oct 1996
SURGICADE GAUZE SPONGE
K962972 · Accunex Canada,Inc. · Oct 1996
PRO-FECT STERILE GAUZE SPONGES
K962227 · Network Trading Corp. Dba Grand Intl. · Aug 1996
PROTEC STERILE GAUZE SPONGE
K961773 · Derivadas Degasa S.A. DE C.V. · Jul 1996
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · Smith & Nephew United, Inc. · Jul 1996