PIEZOSURGERY FLEX

Instrument, Surgical, Sonic And Accessory/attachment

MECTRON S.P.A.

The following data is part of a premarket notification filed by Mectron S.p.a. with the FDA for Piezosurgery Flex.

Pre-market Notification Details

• Device ID: K132848
• 510k Number: K132848
• Device Name: PIEZOSURGERY FLEX
• Classification: Instrument, Surgical, Sonic And Accessory/attachment
• Applicant: MECTRON S.P.A. PIAZZA ALBANIA 10 Rome, IT 00153
• Contact: Roger Gray
• Correspondent: Roger Gray; MECTRON S.P.A. PIAZZA ALBANIA 10 Rome, IT 00153
• Product Code: JDX
• Subsequent Product Code: DZI
• Subsequent Product Code: ERL
• Subsequent Product Code: HBE
• Subsequent Product Code: HWE
• CFR Regulation Number: 888.4580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-11
• Decision Date: 2013-11-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E322051700020020	K132848	000
E322040000950	K132848	000
E322036000160	K132848	000
E322036100100	K132848	000
E322036000190	K132848	000