SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS

Arthroscope

SMITH & NEPHEW ENDOSCOPY, INC.

The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Smith & Nephew Intelijet Fluid Management Systems.

Pre-market Notification Details

• Device ID: K050580
• 510k Number: K050580
• Device Name: SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
• Classification: Arthroscope
• Applicant: SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810
• Contact: Kathleen Burns
• Correspondent: Kathleen Burns; SMITH & NEPHEW ENDOSCOPY, INC. 150 Minuteman Road Andover, MA 01810
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-07
• Decision Date: 2005-04-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556609972	K050580	000
00885556603352	K050580	000
00885556603345	K050580	000
00885556603338	K050580	000
03596010493736	K050580	000