ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES

Electrosurgical, Cutting & Coagulation & Accessories

ORATEC INTERVENTIONS, INC.

The following data is part of a premarket notification filed by Oratec Interventions, Inc. with the FDA for Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System And Accessories.

Pre-market Notification Details

• Device ID: K991140
• 510k Number: K991140
• Device Name: ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025
• Contact: Sheila Ramerman
• Correspondent: Sheila Ramerman; ORATEC INTERVENTIONS, INC. 3700 HAVEN CT. Menlo Park, CA 94025
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-05
• Decision Date: 1999-10-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010613561	K991140	000
00885554013160	K991140	000
00885554012996	K991140	000
00885554012378	K991140	000
00885554011951	K991140	000
00885554011890	K991140	000
00885554011715	K991140	000
00885554011142	K991140	000
00885554010770	K991140	000
00885554008609	K991140	000
00885554007930	K991140	000
00885554007602	K991140	000
00885554007404	K991140	000
00885554006834	K991140	000
00885554015829	K991140	000
00885554031232	K991140	000
00885556539651	K991140	000
03596010612793	K991140	000
03596010554024	K991140	000
03596010542182	K991140	000
03596010534408	K991140	000
03596010519405	K991140	000
03596010519399	K991140	000
03596010492326	K991140	000
03596010480521	K991140	000
03596010470591	K991140	000
03596010470546	K991140	000
00885556603321	K991140	000
00885556586358	K991140	000
00885556586341	K991140	000
00885554006353	K991140	000