Cleared Traditional

K191345 - Pegasus System

K191345 is the FDA 510(k) clearance for Pegasus System by A.M. Surgical, Inc.. It is a Class 2 General & Plastic Surgery device (product code HRX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K191345 · A.M. Surgical, Inc. · General & Plastic Surgery device
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Jul 2019
Decision
58d
Days
Class 2
Risk

K191345 is an FDA 510(k) clearance for the Pegasus System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by A.M. Surgical, Inc. (Smithtown, US). The FDA issued a Cleared decision on July 17, 2019 after a review of 58 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 A.M. Surgical, Inc. devices

Submission Details

510(k) Number K191345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2019
Decision Date July 17, 2019
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HRX Arthroscope

All 356
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K191345.
HydroCision SpineJet System
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Arcadia Balloon Catheter
K191596 · Merit Medical Systems, Inc. · Oct 2019
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · Smith & Nephew, Inc. · Sep 2019
Stryker CrossFlow Integrated Arthroscopy Pump
K191259 · Stryker Corp. · Jul 2019
Voyant System
K191579 · Viseon, Inc. · Jul 2019
Nuvis Battery Arthroscope
K191594 · Integrated Endoscopy, Inc. · Jul 2019