Versavit
FDA 510(k) K121675 · Synergetics, Inc.
510(k) numberK121675
Submission
- Device name
- Versavit
- Applicant
- Synergetics, Inc.
O' Fallon, MO, US - Received
- June 6, 2012
- Decision date
- June 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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Questions and answers
When was Versavit cleared by the FDA?
Versavit (K121675) received a 510(k) decision of Substantially Equivalent on June 21, 2012, 15 days after the submission was received.
What is the product code of K121675?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.