Class Class II
Monotime and Optime R (K233265)
Description
Monotime and Optime R by Peters Surgical, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233265
Clearance Date2024-10-11
Clearance TypeAbbreviated
Product CodeGAM
Regulation Number878.4493
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233265
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Monotime and Optime R (K233265) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K031286 | SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE | Aesculap, Inc. | 2003 |
Trace the full predicate network for K233265
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.