NEEDLE

Endoscopic Injection Needle, Gastroenterology-urology

UNITED STATES ENDOSCOPY GROUP, INC.

The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Needle.

Pre-market Notification Details

• Device ID: K924102
• 510k Number: K924102
• Device Name: NEEDLE
• Classification: Endoscopic Injection Needle, Gastroenterology-urology
• Applicant: UNITED STATES ENDOSCOPY GROUP, INC. 9905 HOBART RD. Waite Hill, OH 44094
• Contact: Marlin Younker
• Correspondent: Marlin Younker; UNITED STATES ENDOSCOPY GROUP, INC. 9905 HOBART RD. Waite Hill, OH 44094
• Product Code: FBK
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-08-13
• Decision Date: 1992-11-25