Cleared Traditional

K961061 - CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)

K961061 · Codi International BV · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
80d
Days
-
Risk

K961061 is an FDA 510(k) clearance for the CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE). Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Codi International BV (Boston, US). The FDA issued a Cleared decision on June 6, 1996 after a review of 80 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 Codi International BV devices

FDA 510(k) Submission Details - K961061

510(k) Number K961061 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 18, 1996
Decision Date June 06, 1996
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 K961061.
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
STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
K962234 · Howard Medical Co. · Jun 1996
EMERALD STERILE GAUZE SPONGE
K961581 · Emerald Medical, Inc. · May 1996
NHMC DRESSING TRAY
K960523 · National Healthcare Mfg. Corp. · Apr 1996
DYNAREX NON-WOVEN SPONGE
K960388 · Dynarex Corp. · Apr 1996