ClearanceBrief
Panels › General, Plastic Surgery › Product code GCY · Class 1

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Regulation 878.4680

0510(k)s in 12 months (96 all time)
0recalls in 12 months (107 all time)
9recalls that name a 510(k)
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Top companies in GCY

Company510(k)sRecalls
Zimmer Inc.036
Aspen Surgical Products, Inc.021
Terumo Cardiovascular Systems Corporation012
Cardinal Health 200, LLC011
Stryker Instruments Div. of Stryker Corporation08
Vital Concepts, Inc.06
Snyder Laboratories, Inc.50
Davol, Inc.40
Pudenz-Schulte Medical Research Corp.40
Sherwood Medical Co.40
DateFirm and productCodeLinked 510(k)
Aug 25, 2004Cardinal Health
Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx device, individually packaged, 10 drains per box, 8 boxes per case; catalog #JP-HUR880; Allegiance H
Terminated		 GCYNone listed
Oct 15, 2003Vital Concepts, Inc.
Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Disposable (single use only), sterile, latex free. Catalog # 55050. HYDRO-PRO brand labeled as sold by Vital C
Terminated		 GCYK934382
K960616
Oct 15, 2003Vital Concepts, Inc.
Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Techno
Terminated		 GCYK934382
K960616
Oct 15, 2003Vital Concepts, Inc.
HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Terminated		 GCYK934382
K960616
Oct 15, 2003Vital Concepts, Inc.
HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Terminated		 GCYK934382
K960616
Oct 15, 2003Vital Concepts, Inc.
Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Gr
Terminated		 GCYK934382
K960616
Oct 15, 2003Vital Concepts, Inc.
Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Hu
Terminated		 GCYK934382
K960616

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