K233265
- 510(k) number
- K233265
- Device name
- Monotime and Optime R
- Applicant
- Peters Surgical MA · US
- Product code
- GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
- Decision date
- 2024-10-11
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K233265.pdf
Official FDA record: K233265
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.