SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE

Electrocautery, Gynecologic (and Accessories)

ASPEN LABS

The following data is part of a premarket notification filed by Aspen Labs with the FDA for Single Use Tungsten Wire Lee Loop Electrode.

Pre-market Notification Details

• Device ID: K925333
• 510k Number: K925333
• Device Name: SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
• Classification: Electrocautery, Gynecologic (and Accessories)
• Applicant: ASPEN LABS P.O. BOX 3936 Englewood, CO 80155
• Contact: Jane Johnson
• Correspondent: Jane Johnson; ASPEN LABS P.O. BOX 3936 Englewood, CO 80155
• Product Code: HGI
• CFR Regulation Number: 884.4120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-10-21
• Decision Date: 1994-09-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20653405010231	K925333	000
20653405010224	K925333	000
20653405010217	K925333	000