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Mersilene Sutures

by Hancock Laboratories, Inc.

510(k) K790534

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790534 Date26 Mar 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KRH
Device Class
Class II
Regulation
21 CFR Part 870.3800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Mersilene Sutures are synthetic, absorbable surgical sutures designed for cardiovascular applications. They are classified as a Ring, Annuloplasty device under FDA regulation 870.3800, intended for use in reconstructive procedures of the mitral or tricuspid heart valves to address valvular insufficiency. The sutures are engineered to provide structural support and durability during cardiac repair.

These sutures are supplied in sterile, single-use packaging and are regulated under FDA 510(k) clearance (K790534) with a classification of Class II. They are intended for use in controlled surgical environments, such as operating rooms, and must be stored according to manufacturer guidelines to maintain sterility. The product code KRH identifies this device within the regulatory database, and its use is governed by cardiovascular surgical protocols.

Other devices from Hancock Laboratories, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Mersilene Sutures designed for in cardiovascular surgery?

    Mersilene Sutures are specifically engineered for reconstructive procedures of the mitral or tricuspid heart valves. They address valvular insufficiency by providing structural support and durability during cardiac repair, ensuring long-term stability of the repaired valve.

  • Are Mersilene Sutures single-use or reusable, and how should they be stored?

    Mersilene Sutures are supplied in sterile, single-use packaging to maintain integrity and prevent contamination. They must be stored according to the manufacturer’s guidelines to preserve sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures.

  • What regulatory pathway does Mersilene Sutures follow, and what classification does it hold?

    Mersilene Sutures are classified under FDA regulation 870.3800 as a Ring, Annuloplasty device and hold a Class II designation. They were cleared via a traditional 510(k) pathway (K790534) in 1979, with a decision of Substantially Equivalent by the Cardiovascular Advisory Committee.

  • What product codes or identifiers are associated with Mersilene Sutures in regulatory databases?

    Mersilene Sutures are identified by the product code KRH in regulatory records. They also appear under multiple registration numbers (e.g., 2015691, 3015287573) and FEI numbers (e.g., 2015691, 3005334138) in the FDA’s OpenFDA database, reflecting their classification as a cardiovascular device.

  • Where are Mersilene Sutures intended for use, and what surgical environment is required?

    Mersilene Sutures are intended exclusively for use in controlled surgical environments, such as operating rooms, during cardiovascular procedures. Their design ensures compatibility with reconstructive techniques for mitral or tricuspid valves, requiring sterile conditions and proper handling to avoid compromise of sterility or performance.