Non-Absorbable Black Silk Suture

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

PMA Number

N83074 ↗

FDA Product Code

CAP

Device Class

Class II

Regulation

21 CFR Part 868.2600

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S001

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• What types of surgical procedures is this black silk suture designed for, and why is it preferred in those settings?

  This non-absorbable black silk suture is designed for ligating blood vessels, approximating tissue edges, and closing wounds in general and plastic surgery. It is preferred in these settings due to its strength, flexibility, and minimal tissue reaction, which help reduce irritation and promote healing while maintaining wound integrity over time.

• Is this suture meant for reuse, or is it intended for single-use only? How should it be stored to maintain sterility?

  This black silk suture is intended for single-use only and is supplied sterile. To maintain sterility, it must be stored in its original packaging, protected from moisture, heat, and direct sunlight, and kept in a clean, dry environment as specified by the manufacturer.

• What regulatory pathway was followed for this device, and what does that mean for its use in clinical settings?

  This suture was authorized under the FDA Premarket Approval (PMA) pathway (PMA N83074), meaning it underwent rigorous review to ensure safety and effectiveness for its intended surgical uses. This approval allows its use in controlled clinical settings like operating rooms, where proper handling and sterile techniques are maintained.

• How does the color of this suture (black) benefit surgeons during procedures?

  The black color of this silk suture enhances visibility against most tissue types, helping surgeons distinguish it from surrounding anatomical structures and improving precision during suturing, especially in deeper or darker tissue areas.