Cleared Traditional

K984187 - CROSSTEX NON-WOVEN SPONGES

K984187 · Crosstex Intl. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
87d
Days
-
Risk

K984187 is an FDA 510(k) clearance for the CROSSTEX NON-WOVEN SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Crosstex Intl. (Great Neck,, US). The FDA issued a Cleared decision on February 18, 1999 after a review of 87 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 Crosstex Intl. devices

FDA 510(k) Submission Details - K984187

510(k) Number K984187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date February 18, 1999
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 140
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K984187.
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
K990584 · Broadline Medical Industries · Apr 1999
GAUZE, SPONGES, CAT # 11-003
K983016 · Vitalcare Group, Inc. · Feb 1999
DYNAREX TRACHEOSTOMY SPONGE
K983348 · Dynarex Corp. · Dec 1998
STARRYSHINE GAUZE SPONGE
K983450 · T.C. Dental Products, Inc. · Nov 1998
JOAN II
K982648 · Celanese Acetate Co. · Sep 1998
DUMEX PAK-ITS WOVEN RIBBON PACKING
K980791 · Dumex Medical Surgical Products, Ltd. · Apr 1998