Cleared Traditional

ENVINET(TM)

K874551 · Marion Laboratories, Inc. · General & Plastic Surgery
Jan 1988
Decision
79d
Days
—
Risk

About This 510(k) Submission

K874551 is an FDA 510(k) clearance for the ENVINET(TM), a Gauze/sponge, Internal, submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 22, 1988, 79 days after receiving the submission on November 4, 1987. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K874551 FDA.gov
FDA Decision Cleared SN
Date Received November 04, 1987
Decision Date January 22, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

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