MediBot Needle Driver Uno— 510(k) K260183

Name: FDA 510(k) clearance K260183
Creator: U.S. Food and Drug Administration
Published: 2026-05-24

Substantially Equivalent

Parallel Robotics, LLC

FDA 510(k) clearance K260183 for MediBot Needle Driver Uno, Substantially Equivalent on 2026-05-24. Applicant: Parallel Robotics, LLC. Device class: 2.

Summary

Parallel Robotics' MediBot Needle Driver Uno is filed under GCJ, general and plastic surgery laparoscopes.

Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.

Parallel Robotics filed from Ann Arbor, Michigan. The decision came 123 calendar days after receipt (January 21 to May 24, 2026).

Clearance details

Applicant: Parallel Robotics, LLC
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-01-21
Decision date: 2026-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.