Cleared Traditional

FLUFF GAUZE SPONGE

K945020 · Clinical Resources, Inc. · General & Plastic Surgery
Dec 1994
Decision
72d
Days
Risk

About This 510(k) Submission

K945020 is an FDA 510(k) clearance for the FLUFF GAUZE SPONGE, a Gauze/sponge, Internal, submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on December 23, 1994, 72 days after receiving the submission on October 12, 1994. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K945020 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1994
Decision Date December 23, 1994
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code EFQ — Gauze/sponge, Internal
Device Class

Similar Devices — EFQ Gauze/sponge, Internal

All 270
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
K991757 · Furlong Industries · Aug 1999
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
K991215 · Symtex Healthcare Corp. · Jun 1999
VITOP DRESSING
K990974 · Wonder & Bioenergy Hi-Tech America, Inc. · Jun 1999
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
K990584 · Broadline Medical Industries · Apr 1999
CROSSTEX NON-WOVEN SPONGES
K984187 · Crosstex Intl. · Feb 1999
GAUZE, SPONGES, CAT # 11-003
K983016 · Vitalcare Group, Inc. · Feb 1999