HandX Instrument - Monopolar Spatula

FDA 510(k) K222011 · Human Xtensions , Ltd.

Substantially Equivalent

510(k) numberK222011

Submission

Device name
HandX Instrument - Monopolar Spatula
Applicant
Human Xtensions , Ltd.
Netanya, IL
Received
July 7, 2022
Decision date
January 12, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GCJ – Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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More from TroCare, LLC

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K223718HandX™ Self-Righting Needle HolderGCJ · Traditional 06/05/2023SE
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K212214HandXGCJ · Traditional 09/13/2021SE
K203603Monopolar HookGCJ · Traditional 02/01/2021SE

Questions and answers

When was HandX Instrument - Monopolar Spatula cleared by the FDA?

HandX Instrument - Monopolar Spatula (K222011) received a 510(k) decision of Substantially Equivalent on January 12, 2023, 189 days after the submission was received.

What is the product code of K222011?

The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.