Who is the manufacturer of POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP?

Arc Medical Supplies (Beijing) Co, Ltd. submitted the Traditional clearance for POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP (K000537).

What is the FDA product code for POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP?

GAW. It is classified under 21 CFR 878.5010 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP?

510(k) clearance (submission type: Traditional).

POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP

K000537 · Arc Medical Supplies (Beijing) Co, Ltd. · GAW · Apr 27, 2000 · General, Plastic Surgery

Device Facts

Record ID	K000537
Device Name	POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
Applicant	Arc Medical Supplies (Beijing) Co, Ltd.
Product Code	GAW · General, Plastic Surgery
Decision Date	Apr 27, 2000
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 878.5010
Device Class	Class 2

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

Special Controls

*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.