Cleared Special

K112456 - ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT

K112456 is an FDA 510(k) clearance for ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS..., manufactured by Teleflexmedical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 40-day FDA review.

K112456 · Teleflexmedical, Inc. · General & Plastic Surgery device
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Oct 2011
Decision
40d
Days
Class 2
Risk

K112456 is an FDA 510(k) clearance for the ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on October 4, 2011 after a review of 40 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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K112456

510(k) Number K112456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2011
Decision Date October 04, 2011
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCJ Laparoscope, General & Plastic Surgery

All 1015
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