KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1

Insufflator, Laparoscopic

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Electronic Co2 Endoflator Lc, Model 26430320-1.

Pre-market Notification Details

• Device ID: K080852
• 510k Number: K080852
• Device Name: KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
• Classification: Insufflator, Laparoscopic
• Applicant: KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Contact: Crystal Dizol
• Correspondent: Crystal Dizol; KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Product Code: HIF
• CFR Regulation Number: 884.1730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-26
• Decision Date: 2009-03-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551068830	K080852	000