Cleared Special

K193036 - C2 CryoBalloon EndoGrip

K193036 is the FDA 510(k) clearance for C2 CryoBalloon EndoGrip by Pentax Medical, A Division of Pentax of America, Inc.. It is a Class 2 General & Plastic Surgery device (product code OCX) cleared through the Special 510(k) pathway after a 22-day FDA review.

K193036 · Pentax Medical, A Division of Pentax of America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Nov 2019
Decision
22d
Days
Class 2
Risk

K193036 is an FDA 510(k) clearance for the C2 CryoBalloon EndoGrip. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Pentax Medical, A Division of Pentax of America, Inc. (Redwood, Ca, US). The FDA issued a Cleared decision on November 22, 2019 after a review of 22 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pentax Medical, A Division of Pentax of America, Inc. devices

Submission Details

510(k) Number K193036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2019
Decision Date November 22, 2019
Days to Decision 22 days
Submission Type Special
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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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 - OCX Endoscopic Irrigation/suction System

All 58
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