CRYOPROBE

Unit, Cryosurgical, Accessories

H&O EQUIPMENTS NV/SA

The following data is part of a premarket notification filed by H&o Equipments Nv/sa with the FDA for Cryoprobe.

Pre-market Notification Details

• Device ID: K024009
• 510k Number: K024009
• Device Name: CRYOPROBE
• Classification: Unit, Cryosurgical, Accessories
• Applicant: H&O EQUIPMENTS NV/SA 4655 KIRKWOOD CT. Boulder, CO 80301
• Contact: Lewis Ward
• Correspondent: Lewis Ward; H&O EQUIPMENTS NV/SA 4655 KIRKWOOD CT. Boulder, CO 80301
• Product Code: GEH
• CFR Regulation Number: 878.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-12-04
• Decision Date: 2003-03-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15407008481022	K024009	000
15407008481404	K024009	000
15407008483309	K024009	000
25407008484105	K024009	000
25407008484303	K024009	000
25407008482101	K024009	000
25407008484006	K024009	000
25407008484204	K024009	000
25407008482309	K024009	000
25407008482507	K024009	000
15407008481107	K024009	000
15407008481503	K024009	000
15407008481305	K024009	000
15407008481206	K024009	000
15407008481114	K024009	000
15407008481213	K024009	000
15407008481312	K024009	000
15407008481510	K024009	000
15407008483118	K024009	000
15407008483316	K024009	000
15407008483514	K024009	000
15407008481602	K024009	000
B386CLFPU020	K024009	000
B386CLFPU180	K024009	000
15407008481008	K024009	000
15407008483101	K024009	000
B386CLN2O16GUNCARTON2	K024009	000
B386CLN2O8GUNCARTON2	K024009	000
B386SHOCOPR010	K024009	000
B386SHOCXPRMED0	K024009	000
B386SHOCXPRP000	K024009	000
B386SHOCXPRP010	K024009	000
B386SHOCXPRP020	K024009	000
B386SHOCXPRPODO0	K024009	000
B386SHOCXPRXX8010	K024009	000
B386SHONO2312S06PR2	K024009	000
B386SHONOCX12S24PR2	K024009	000
B386SHONOCXPR12S062	K024009	000
B386SNOR112	K024009	000
B386SHOCMPRXX9020	K024009	000
B386SHOCBPLUSPR040	K024009	000
B386SHOCBPLUSPR050	K024009	000
B386SHOCEPR000	K024009	000
15407008483507	K024009	000
25407008484501	K024009	000
B386CLFP000	K024009	000
B386CLFP010	K024009	000
B386CLFP160	K024009	000
B386CLN2O8GCARTON2	K024009	000
B386SHOCBPLUSPR010	K024009	000
B386SHOCBPLUSPR020	K024009	000
B386SHOCBPLUSPR030	K024009	000
B386STOUCH300	K024009	000