Cleared Traditional

MIDAScope and Introducer Kit, and MIDASystem (K181982) - FDA 510(k) Clearance

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

K181982 · Intravu, Inc. · General & Plastic Surgery device
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Aug 2018
Decision
27d
Days
Class 2
Risk

K181982 is an FDA 510(k) clearance for the MIDAScope and Introducer Kit, and MIDASystem. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Intravu, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 21, 2018 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.1100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intravu, Inc. devices

Submission Details

510(k) Number K181982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2018
Decision Date August 21, 2018
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition 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).
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

Third Party Review Group, LLC
DAVE YUNGVIRT

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 - HRX Arthroscope

All 188
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K181982.
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
K182882 · Conmed Corporation · Nov 2018
SMARTRELEASE Endoscopic Soft Tissue Release System
K181819 · Microaire Surgical Instruments, LLC · Nov 2018
Voyant System
K181885 · Viseon, Inc. · Oct 2018
Endiscope, Endiscope Cervical
K180766 · Elliquence, LLC · Jun 2018
Single Use Arthroscopic Electrode (with Pencil)
K170703 · Modern Medical Equipment Manufacturing Limited · May 2018
DTRAX Spinal System
K180876 · Providence Medical Technology, Inc. · May 2018

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.