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SurgiSure Tissue Removal System

by Interlace Medical, Inc.

510(k) K103741

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 NumberK103741 Date2 Mar 2011ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The SurgiSure Tissue Removal System is a surgical device classified as a tissue morcellator (Product Code GCJ) under FDA nomenclature. It is designed for the fragmentation (morcellation) and removal of dissected tissue during minimally invasive procedures, including laparoscopic, percutaneous, and open surgeries where surgical access is constrained.

The system is intended for use under direct or endoscopic visualization and is supplied as a reusable medical device. It has received FDA 510(k) clearance under the Traditional review pathway, with no third-party involvement. No specific sterility or MRI safety information is provided in the regulatory data.

Other devices from Interlace Medical, Inc.

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of surgical procedures is the SurgiSure Tissue Removal System intended for, and how does it differ from standard tissue removal tools?

    The SurgiSure Tissue Removal System is specifically designed for fragmenting (morcellating) and removing dissected tissue during minimally invasive surgeries where access is limited, such as laparoscopic, percutaneous, or open procedures. Unlike traditional tools, it is optimized for constrained environments where direct or endoscopic visualization is required, ensuring precise tissue handling without the need for additional extraction methods.

  • Is the SurgiSure Tissue Removal System single-use or reusable, and what does that mean for maintenance and cost?

    The SurgiSure Tissue Removal System is reusable, meaning it is intended for repeated use after proper cleaning, sterilization, and maintenance. This design choice can reduce per-procedure costs over time, though facilities must account for cleaning protocols, storage, and potential wear-and-tear between uses.

  • How is the device supplied, and what should clinicians expect when receiving their first shipment?

    The SurgiSure Tissue Removal System is supplied as a complete reusable kit for surgical use. Since no sterility information is specified in the regulatory data, clinicians should confirm the manufacturer’s recommended cleaning and reprocessing instructions before first use. The system is intended for direct surgical application under visualization, so compatibility with existing laparoscopic or open surgery setups is assumed.

  • What regulatory pathway was followed for FDA clearance, and does this system involve any third-party involvement?

    The SurgiSure Tissue Removal System received FDA 510(k) clearance under the Traditional review pathway, meaning the manufacturer demonstrated substantial equivalence to a legally marketed predicate device. There was no third-party involvement in the review process, and the clearance was granted by the FDA’s Gastroenterology and Urology advisory committees (GU/SU).