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Mangum Knot Pusher

by Innovative Surgical, Inc.

510(k) K945394

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 NumberK945394 Date27 Jan 1995ClearedStatusActive

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  • Withdrawn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)

Full name
Innovative Surgical(R) Mangum Knot Pusher
510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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.

The Mangum Knot Pusher is a surgical instrument classified under the product code GCJ, designed to assist in the placement and manipulation of suture knots during laparoscopic procedures. It facilitates knot tying outside the body and aids in securing sutures within the surgical field with precision. This device is specifically engineered to enhance efficiency in minimally invasive surgeries, particularly in gastroenterology and urology applications.

The Mangum Knot Pusher is supplied as a reusable surgical tool and is intended for use in sterile environments. It is not MRI-safe and must be handled according to standard surgical instrument protocols. The device holds an FDA 510(k) clearance (K945394) under the Traditional pathway, with a clearance date of January 27, 1995. Storage and maintenance should adhere to manufacturer guidelines for reusable surgical instruments to ensure sterility and functionality.

Other devices from Innovative Surgical, 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 is the Mangum Knot Pusher used for?

    The Mangum Knot Pusher is a reusable surgical instrument designed specifically for laparoscopic procedures. It assists in placing and manipulating suture knots outside the body, allowing for precise knot tying and secure suture placement within the surgical field. This is particularly useful in minimally invasive surgeries, especially in gastroenterology and urology applications, where efficiency and accuracy are critical.

  • Is the Mangum Knot Pusher single-use or reusable?

    The Mangum Knot Pusher is supplied as a reusable surgical tool. Like other reusable instruments, it must be cleaned, sterilized, and maintained according to strict manufacturer guidelines to ensure sterility and functionality for repeated use in sterile environments.

  • What are the key applications for this device?

    This device is engineered to enhance efficiency in minimally invasive surgeries, particularly in gastroenterology and urology. Its design supports the precise placement and securing of suture knots during laparoscopic procedures, reducing the complexity of knot tying within the surgical field.

  • How should the Mangum Knot Pusher be stored?

    Storage and maintenance of the Mangum Knot Pusher must follow manufacturer guidelines for reusable surgical instruments. Proper storage ensures the device remains sterile and functional for future use, adhering to standard surgical instrument protocols.

  • Is the Mangum Knot Pusher MRI-safe?

    No, the Mangum Knot Pusher is not MRI-safe. This means it should not be used or stored in an MRI environment, as it could interfere with imaging or pose a risk to patients and staff.