GyneGuide

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894591 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Mclaughlin Laparoscopic Grasper

  Class II

  FDA 510(k) K910578 Active Cleared 3 Apr 1991

• Marlow Suction/Irrigation Probes

  Class II

  FDA 510(k) K914872 Active Cleared 19 Nov 1991

• Pal (Probe for Aspiration and Lavage)

  Class II

  FDA 510(k) K911149 Active Cleared 5 Jul 1991

• Marlow/Reddick Laparoscopic Needle Holders

  Class II

  FDA 510(k) K913954 Active Cleared 18 Dec 1991

• Reich Suction/Irrigation Cannula

  Class II

  FDA 510(k) K911164 Active Cleared 5 Jul 1991

• Clarke Laparoscopic Ligator and Forceps

  Class II

  FDA 510(k) K903560 Active Cleared 6 Nov 1990

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• What is the GyneGuide used for in surgical procedures?

  The GyneGuide is a powered laser surgical instrument designed for precise tissue ablation, coagulation, or vaporisation. It is specifically intended for general and plastic surgery applications where controlled energy delivery is critical, such as cutting, sealing blood vessels, or removing tissue with minimal thermal damage. Its laser technology allows for enhanced precision compared to traditional surgical tools, making it suitable for procedures requiring fine control.

• Is the GyneGuide a single-use or reusable device?

  The GyneGuide is supplied as a reusable medical device. Reusability is common for high-cost, high-performance surgical instruments like this one, as it allows for cost-effective use across multiple procedures while maintaining regulatory compliance. However, proper sterilisation and maintenance are essential to ensure its safe and effective reuse in sterile surgical environments.

• What regulatory pathway does the GyneGuide follow, and when was it cleared?

  The GyneGuide was cleared via the FDA’s Traditional 510(k) pathway under clearance number K894591. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device. The clearance was granted on October 10, 1989, and it falls under the General & Plastic Surgery category (Product Code: GEX). The device is regulated under FDA regulation 878.4810.

• Does the GyneGuide have any specific safety considerations for use?

  The GyneGuide requires adherence to standard laser safety protocols due to its powered laser technology. Since it is intended for use in sterile surgical environments, proper handling, maintenance, and storage are critical to prevent contamination or operational failure. Users must follow manufacturer guidelines for storage and maintenance to ensure the device remains functional and safe for repeated use.

• Are there any special storage requirements for the GyneGuide?

  While the device data does not specify unique storage conditions beyond standard medical device maintenance, the GyneGuide must be stored in a clean, dry environment to prevent damage or contamination. Since it is reusable, it should be cleaned, sterilised, and inspected according to the manufacturer’s instructions between uses. Proper storage ensures operational integrity and compliance with regulatory expectations for reusable surgical instruments.