Cleared Traditional

STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE

K852202 · Ormed Mfg., Inc. · General & Plastic Surgery
Jun 1985
Decision
36d
Days
—
Risk

About This 510(k) Submission

K852202 is an FDA 510(k) clearance for the STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE, a Gauze/sponge, Internal, submitted by Ormed Mfg., Inc. (Buffalo, US). The FDA issued a Cleared decision on June 26, 1985, 36 days after receiving the submission on May 21, 1985. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K852202 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1985
Decision Date June 26, 1985
Days to Decision 36 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