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SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT - CS33

by Powermed, Inc.

510(k) K003277

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK003277 Date21 Dec 2000ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0392-2010 FDA Unclassified (pre-2012) initiated 23 Sep 2009

    Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.

  • 2 recalls, same reason

    • Terminated Z-1048-03 FDA Unclassified (pre-2012) initiated 30 Jun 2003 on shared 510(k) K003277
    • Terminated Z-1049-03 FDA Unclassified (pre-2012) initiated 30 Jun 2003 on shared 510(k) K003277

    latching mechanism failure

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
GDW
Models / Variants
CS33
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
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 Surgassist System with Circular Stapler Disposable Loading Unit is classified as an implantable staple device. It features disposable loading units equipped with titanium staples and integrated cutting blades, designed to create precise, double-staggered circular rows of staples through tissue. This mechanism facilitates controlled anastomosis of tubular structures, such as those found in gastrointestinal or vascular surgeries, ensuring secure tissue approximation.

The system is intended for single-use in surgical settings and requires no sterilization. Each disposable loading unit (Models CS21, CS25, CS29, CS33) is non-reusable and must be discarded post-procedure. The device is FDA-cleared under a 510(k) submission (K003277) and falls under Class II regulatory classification (878.4750). Compatibility with MRI is not specified, and storage conditions align with standard sterile surgical instrument protocols.

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 Surgassist System with Circular Stapler Disposable Loading Unit used for?

    The Surgassist System with Circular Stapler Disposable Loading Unit is designed for creating precise, double-staggered circular rows of staples through tissue. This facilitates controlled anastomosis—surgical connections—of tubular structures, such as those in gastrointestinal or vascular surgeries. The titanium staples and integrated cutting blades ensure secure tissue approximation, reducing the risk of leakage or dehiscence.

  • Are the disposable loading units reusable or single-use?

    The disposable loading units (Models CS21, CS25, CS29, CS33) are explicitly intended for single-use only. They must be discarded immediately after a surgical procedure to maintain sterility and performance. Reuse is not supported by the manufacturer and could compromise safety or functionality.

  • What storage conditions apply to the Surgassist System?

    The system follows standard sterile surgical instrument protocols for storage. This means the disposable loading units should be kept in their original packaging until use, protected from moisture, extreme temperatures, and physical damage. Avoid exposure to direct sunlight or contaminants. The manufacturer does not specify MRI compatibility, so caution is advised if MRI is planned post-implantation.

  • How do the different models (CS21, CS25, CS29, CS33) differ?

    The models CS21, CS25, CS29, and CS33 represent variations in the circumferential size or staple configuration of the disposable loading units. While exact measurements aren’t detailed, these distinctions likely accommodate different tissue diameters or surgical requirements (e.g., smaller bowel vs. larger vascular anastomoses). Consult the manufacturer’s technical documentation for specific sizing guidance tailored to your procedure.

  • Does the Surgassist System require sterilization before use?

    No, the disposable loading units are sterile as packaged and intended for single-use only. They do not require additional sterilization procedures like autoclaving or ethylene oxide treatment. Opening the packaging compromises sterility, so only use intact, unopened units in a sterile surgical environment.