KSEA POWERSHAVER SYSTEM S2

Arthroscope

KARL STORZ ENDOSCOPY

The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Powershaver System S2.

Pre-market Notification Details

• Device ID: K030009
• 510k Number: K030009
• Device Name: KSEA POWERSHAVER SYSTEM S2
• Classification: Arthroscope
• Applicant: KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Contact: Renate A Maclaren
• Correspondent: Renate A Maclaren; KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-01-02
• Decision Date: 2003-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551109502	K030009	000
04048551109861	K030009	000
04048551109885	K030009	000
04048551109892	K030009	000
04048551109915	K030009	000
04048551109922	K030009	000
04048551109939	K030009	000
04048551109953	K030009	000
04048551109960	K030009	000
04048551109984	K030009	000
04048551109991	K030009	000
04048551110003	K030009	000
04048551110027	K030009	000
04048551109854	K030009	000
04048551109847	K030009	000
04048551109519	K030009	000
04048551109533	K030009	000
04048551109571	K030009	000
04048551109588	K030009	000
04048551109618	K030009	000
04048551109632	K030009	000
04048551109656	K030009	000
04048551109663	K030009	000
04048551109687	K030009	000
04048551109816	K030009	000
04048551109823	K030009	000
04048551109830	K030009	000
04048551110034	K030009	000
04048551110041	K030009	000
04048551110492	K030009	000
04048551110515	K030009	000
04048551110539	K030009	000
04048551110553	K030009	000
04048551110577	K030009	000
04048551110584	K030009	000
04048551110591	K030009	000
04048551110751	K030009	000
04048551110799	K030009	000
04048551110812	K030009	000
04048551113332	K030009	000
04048551326336	K030009	000
04048551110478	K030009	000
04048551110454	K030009	000
04048551110058	K030009	000
04048551110065	K030009	000
04048551110072	K030009	000
04048551110089	K030009	000
04048551110102	K030009	000
04048551110126	K030009	000
04048551110140	K030009	000
04048551110348	K030009	000
04048551110362	K030009	000
04048551110393	K030009	000
04048551110416	K030009	000
04048551110430	K030009	000
04048551326350	K030009	000