Rocket Electrode
FDA 510(k) K974138 · A & A Medical, Inc.
510(k) numberK974138
Submission
- Device name
- Rocket Electrode
- Applicant
- A & A Medical, Inc.
Alpharetta, GA, US - Received
- November 3, 1997
- Decision date
- January 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGI – Electrocautery, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4120
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Rocket Electrode cleared by the FDA?
Rocket Electrode (K974138) received a 510(k) decision of Substantially Equivalent on January 30, 1998, 88 days after the submission was received.
What is the product code of K974138?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.