16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)

Electrocautery, Gynecologic (and Accessories)

AARON MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for 16 Electrodes (blade, Ball, Needle & Loop).

Pre-market Notification Details

• Device ID: K931338
• 510k Number: K931338
• Device Name: 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
• Classification: Electrocautery, Gynecologic (and Accessories)
• Applicant: AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg, FL 33712
• Contact: Robert Saron
• Correspondent: Robert Saron; AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg, FL 33712
• Product Code: HGI
• CFR Regulation Number: 884.4120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-03-16
• Decision Date: 1994-02-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887482177044	K931338	000
00887482178034	K931338	000
00887482178058	K931338	000
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40080196916352	K931338	000
20193489198536	K931338	000
20193489198703	K931338	000
20193489199601	K931338	000
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00887482181546	K931338	000
20884524000166	K931338	000
00192896011175	K931338	000