Laparoscopic 5MM ABC Probe, Modification

• 4 recalls, same reason

  • Terminated Z-2282-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008
  • Terminated Z-2279-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008
  • Terminated Z-2281-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008
  • Terminated Z-2280-2010 FDA Unclassified (pre-2012) ·initiated 18 Dec 2008

  The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.

510(k) Number

K925903 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Birtcher Swivel Grip Laparoscopic Probes & Access.

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• Birtcher Bronchus & Lung Clamp (Gs-1620 & Gs-1600)

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See all devices from Birtcher Medical Systems, Inc. →

• Is this probe designed for single-use or can it be reused in multiple procedures?

  This probe is explicitly labeled as a reusable instrument, meaning it is intended for use across multiple sterile surgical settings after proper sterilization between cases. Since it is classified under FDA 510(k) clearance (K925903) and must comply with manufacturer sterilization guidelines, it is not disposable.

• What is the primary purpose of the Laparoscopic 5mm ABC Probe in surgical settings?

  The probe serves as an exploratory or diagnostic tool in minimally invasive laparoscopic procedures. It is inserted through a small incision to help visualize or manipulate internal tissues during abdominal or pelvic surgeries, aiding surgeons in assessing or preparing the surgical field.

• How should this device be stored before use to ensure sterility?

  Since it is a reusable instrument, the probe must be sterilized according to the manufacturer’s guidelines before storage. Proper sterilization ensures it remains safe for use in sterile surgical settings. Storage should follow the manufacturer’s recommendations to maintain its integrity and sterility until the next use.

• What size is the probe, and are there multiple sizes available?

  The probe is available in a single size of 5mm diameter. There are no other sizes listed in the specifications, so this is the only variant offered for laparoscopic procedures.