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Hobbs Medical Grasping Forceps

FDA 510(k)

Class II (US FDA 510(k))

510(k) K833125

by Hobbs Medical, Inc.

Identifiers

510(k) Number
K833125 FDA 510(k)
FDA Product Code
OCZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hobbs Medical Grasping Forceps 5030 is an endoscopic grasping/cutting instrument, non-powered, designed for manual use within body cavities. It features a flexible metal coil and plastic tube with a distal end equipped with grasping tongs, controlled via a proximal handle for precise manipulation of foreign bodies during endoscopic procedures.

This device is introduced through the working channel of a compatible endoscope and is intended for single-use applications in gastroenterology and urology. It is classified under regulation number 876.1500 and holds an FDA 510(k) clearance (K833125) with a traditional review pathway, granted in 1983. The product is non-sterile as shipped and requires sterilization prior to use.

Frequently asked questions

What specialties are the Hobbs Medical Grasping Forceps primarily used in, and how does this relate to their design?

The Hobbs Medical Grasping Forceps are designed for use in gastroenterology and urology, as indicated by their advisory committee classification (GU) and medical specialty description. The device’s flexible metal coil and plastic tube, combined with a distal grasping mechanism controlled via a proximal handle, allow precise manipulation of foreign bodies within body cavities—commonly encountered in endoscopic procedures in these specialties.

Is the Hobbs Medical Grasping Forceps intended for reusable or single-use applications, and what does this mean for my workflow?

The device is explicitly labeled for single-use applications only. This means each unit is meant to be used once per patient and then discarded, reducing the need for reprocessing (e.g., sterilization between patients) and minimizing infection risks. However, since it is non-sterile as shipped, it must be sterilized prior to first use, which may require additional workflow planning.

How is the Hobbs Medical Grasping Forceps inserted during an endoscopic procedure, and what compatibility considerations should I keep in mind?

The forceps are introduced through the working channel of a compatible endoscope, meaning the endoscope’s channel diameter and internal dimensions must accommodate the device’s flexible coil and tube. While the exact dimensions aren’t specified, the design suggests it’s engineered for standard endoscopic channels used in gastroenterology and urology. Always verify compatibility with your endoscope model to ensure smooth insertion and operation.

What does the non-sterile packaging mean for my preparation before use, and what sterilization methods are recommended?

Since the Hobbs Medical Grasping Forceps are non-sterile as shipped, they require sterilization before use to ensure patient safety. While the data doesn’t specify sterilization methods, common practices for endoscopic instruments include autoclaving (steam sterilization) or ethylene oxide (ETO) gas sterilization. Always follow your facility’s established protocols and validate compatibility with the manufacturer’s instructions if available.

What does the FDA 510(k) clearance (K833125) with a traditional review pathway indicate about the device’s regulatory history and safety standards?

The FDA 510(k) clearance (granted in 1983) confirms the device meets U.S. regulatory requirements for safety and effectiveness, as determined by the FDA’s review of its substantial equivalence to a legally marketed predicate device. The traditional review pathway means the manufacturer provided detailed submissions to demonstrate compliance with applicable standards, including clinical performance and risk management. This clearance does not imply ongoing changes or updates, so always verify the latest labeling or recalls via the FDA’s database.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Hobbs Medical, HOBBS MEDICAL, INC. 5030 Hobbs Medical Grasping Forceps - RevMed, HOBBS MEDICAL GRASPING FORCEPS (K833125) — FDA 510 (k) | Innolitics, HOBBS MEDICAL, INC. 5030 Hobbs Medical Grasping Forceps - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hobbs Medical, Inc.

Sources (1)

  • FDA 510(k) K833125 24 fields · synced Sep 19, 2026