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Spacemaker Surgical Balloon Dissector & Cannula

by General Surgical Innovations

510(k) K952278

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 NumberK952278 Date7 Aug 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  • Withdrawn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
The Reusable Spacemaker Surgical Balloon Dissector & Cannula
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, 24 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 Spacemaker Surgical Balloon Dissector & Cannula is a handheld, manually manipulated surgical device that creates operative space by separating connective tissue layers along natural planes. It consists of a balloon, center rod, and optional cannula. The device is used to create space for various surgical procedures.

The Spacemaker Surgical Balloon Dissector & Cannula is supplied as a reusable device and is used in the operating room by surgeons. It is available with different configurations, including a cannula that provides a port for surgical access. The device has received FDA 510K clearance, with the reference number K952278.

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Questions

AI-generated answers, 24 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 is the Spacemaker Surgical Balloon Dissector & Cannula used for?

    The Spacemaker Surgical Balloon Dissector & Cannula is used to create space for various surgical procedures by separating connective tissue layers along natural planes.

  • Is the Spacemaker Surgical Balloon Dissector & Cannula reusable?

    Yes, the Spacemaker Surgical Balloon Dissector & Cannula is supplied as a reusable device, intended for repeated use in the operating room.

  • What configurations are available for the Spacemaker Surgical Balloon Dissector & Cannula?

    The device is available with different configurations, including a cannula that provides a port for surgical access, allowing for varying degrees of surgical access and manipulation.

  • What is the regulatory status of the Spacemaker Surgical Balloon Dissector & Cannula?

    The Spacemaker Surgical Balloon Dissector & Cannula has received FDA 510K clearance, with the reference number K952278, indicating substantial equivalence to a predicate device.