Sovereign Cataract Extraction System
FDA 510(k) K981116 · Allergan, Inc.
510(k) numberK981116
Submission
- Device name
- Sovereign Cataract Extraction System
- Applicant
- Allergan, Inc.
Irvine, CA, US - Received
- March 27, 1998
- Decision date
- May 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYG – Device, Irrigation, Ocular Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4360
- Specialty
- Ophthalmic
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Questions and answers
When was Sovereign Cataract Extraction System cleared by the FDA?
Sovereign Cataract Extraction System (K981116) received a 510(k) decision of Substantially Equivalent on May 19, 1998, 53 days after the submission was received.
What is the product code of K981116?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.