Cody Sacculotomy Tack
FDA 510(k) K832068 · Micromedics, Inc.
510(k) numberK832068
Submission
- Device name
- Cody Sacculotomy Tack
- Applicant
- Micromedics, Inc.
Mchenry, IL, US - Received
- June 27, 1983
- Decision date
- October 19, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ESX – Tack, Sacculotomy (Cody Tack)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3760
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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Questions and answers
When was Cody Sacculotomy Tack cleared by the FDA?
Cody Sacculotomy Tack (K832068) received a 510(k) decision of Substantially Equivalent on October 19, 1983, 114 days after the submission was received.
What is the product code of K832068?
The FDA product code is ESX – Tack, Sacculotomy (Cody Tack), a Class II (moderate risk) device regulated under 21 CFR 874.3760.