(89 days)
SERRALNYL™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological procedures.
Not Found
This document is a 510(k) clearance letter from the FDA for Serral S.A. de C.V.'s Serralny1™ Non-absorbable Surgical Sutures. It confirms that the device is substantially equivalent to legally marketed devices.
However, this document does not contain any information regarding acceptance criteria, device performance, or any studies. The letter is a regulatory clearance and precedes the need for such data in a premarket notification, particularly for a Class II device like this, which is typically cleared based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information based on the provided text.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.