HICURA HAND INSTRUMENTS

Electrosurgical, Cutting & Coagulation & Accessories

OLYMPUS WINTER & IBE GMBH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Hicura Hand Instruments.

Pre-market Notification Details

• Device ID: K140624
• 510k Number: K140624
• Device Name: HICURA HAND INSTRUMENTS
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610
• Contact: Sheri L Musgnung
• Correspondent: Sheri L Musgnung; OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-11
• Decision Date: 2014-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04042761078610	K140624	000
04042761078481	K140624	000
04042761078474	K140624	000
04042761078467	K140624	000
04042761078450	K140624	000
04042761078443	K140624	000
04042761078436	K140624	000
04042761078429	K140624	000
04042761078412	K140624	000
04042761078405	K140624	000
04042761078498	K140624	000
04042761078504	K140624	000
04042761078511	K140624	000
04042761078603	K140624	000
04042761078597	K140624	000
04042761078580	K140624	000
04042761078573	K140624	000
04042761078566	K140624	000
04042761078559	K140624	000
04042761078542	K140624	000
04042761078535	K140624	000
04042761078528	K140624	000
04042761078399	K140624	000
04042761078382	K140624	000
04042761078771	K140624	000
04042761078764	K140624	000
04042761078757	K140624	000
04042761078740	K140624	000
04042761078733	K140624	000
04042761078726	K140624	000
04042761078719	K140624	000
04042761078702	K140624	000
04042761078696	K140624	000
04042761079020	K140624	000
04042761079037	K140624	000
04042761079044	K140624	000
04042761078375	K140624	000
04042761078368	K140624	000
04042761078351	K140624	000
04042761078344	K140624	000
04042761079099	K140624	000
04042761079082	K140624	000
04042761079075	K140624	000
04042761079068	K140624	000
04042761079051	K140624	000
04042761078689	K140624	000
04042761078627	K140624	000
04042761083669	K140624	000
04042761078320	K140624	000
04042761078313	K140624	000
04042761078306	K140624	000
04042761078283	K140624	000
04042761078276	K140624	000
04042761078269	K140624	000
04042761079013	K140624	000
04042761079006	K140624	000
04042761078993	K140624	000
04042761078337	K140624	000
04042761079105	K140624	000
04042761079112	K140624	000
04042761083652	K140624	000
04042761083645	K140624	000
04042761079914	K140624	000
04042761079907	K140624	000
04042761079891	K140624	000
04042761078917	K140624	000
04042761078900	K140624	000
04042761079969	K140624	000
04042761079129	K140624	000
04042761078986	K140624	000
04042761078979	K140624	000
04042761078825	K140624	000
04042761078818	K140624	000
04042761078801	K140624	000
04042761078795	K140624	000
04042761078788	K140624	000
04042761078672	K140624	000
04042761078665	K140624	000
04042761078658	K140624	000
04042761078641	K140624	000
04042761078832	K140624	000
04042761078849	K140624	000
04042761078856	K140624	000
04042761078962	K140624	000
04042761078955	K140624	000
04042761078948	K140624	000
04042761078931	K140624	000
04042761078924	K140624	000
04042761078894	K140624	000
04042761078887	K140624	000
04042761078870	K140624	000
04042761078863	K140624	000
04042761078634	K140624	000