(99 days)
UniEster C is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological cardiovascular, procedures.
Not Found
I apologize, but the provided text is a letter from the FDA regarding the 510(k) clearance of the UniEster C surgical suture. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot generate the requested table and study details based on this input.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.