PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP

• K Number: K000542
• Device Name: PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
• Manufacturer: ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
• Date Cleared: 2000-04-28 ( 71 days)
• Product Code: GAL
• Regulation Number: 878.4830

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 878.4830 Absorbable surgical gut suture.

(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.

Summary

N/A