Cleared Traditional

K250539 - Remanufactured EndoWrist Tenaculum Forceps (420207) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250539 · Rebotix · General & Plastic Surgery device
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Aug 2025
Decision
176d
Days
Class 2
Risk

K250539 is an FDA 510(k) clearance for the Remanufactured EndoWrist Tenaculum Forceps (420207). Classified as System, Surgical, Computer Controlled Instrument, Remanufactured (product code QSM), Class II - Special Controls.

Submitted by Rebotix (St. Petersburg, US). The FDA issued a Cleared decision on August 19, 2025 after a review of 176 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Rebotix devices

Submission Details

510(k) Number K250539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2025
Decision Date August 19, 2025
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 114d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QSM System, Surgical, Computer Controlled Instrument, Remanufactured
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition As Intended With The Originally Cleared Instrument.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Ajw Technology Consultants, Inc.
Ryan Burke

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QSM System, Surgical, Computer Controlled Instrument, Remanufactured

All 7
Devices cleared under the same product code (QSM) and FDA review panel - the closest regulatory comparables to K250539.
Robotic Surgical Instruments - Permanent Cautery Hook (470183)
K252926 · Restore Robotics · Mar 2026
Remanufactured EndoWrist Cobra Grasper (420190)
K250417 · Rebotix · Aug 2025
Remanufactured EndoWrist Long Tip Forceps (420048)
K250387 · Rebotix · Aug 2025
Remanufactured EndoWrist Cadiere Forceps (420049)
K250399 · Rebotix · Aug 2025
8mm Monopolar Curved Scissors (470179)
K242610 · Iconocare Health · Mar 2025
Remanufactured EndoWrist ProGrasp Forceps (420093)
K241872 · Rebotix · Nov 2024