FluidSmart

Insufflator, Hysteroscopic

THERMEDX, LLC

The following data is part of a premarket notification filed by Thermedx, Llc with the FDA for Fluidsmart.

Pre-market Notification Details

• Device ID: K172048
• 510k Number: K172048
• Device Name: FluidSmart
• Classification: Insufflator, Hysteroscopic
• Applicant: THERMEDX, LLC 31200 Solon Rd., Unit #1 Solon, OH 44139
• Contact: Homer Gregory
• Correspondent: Homer Gregory; THERMEDX, LLC 31200 Solon Rd., Unit #1 Solon, OH 44139
• Product Code: HIG
• Subsequent Product Code: HRX
• Subsequent Product Code: LGZ
• CFR Regulation Number: 884.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-06
• Decision Date: 2017-09-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20860936000369	K172048	000