Cleared Special

K143221 - Schoelly Laparoscope

K143221 is an FDA 510(k) clearance for Schoelly Laparoscope, manufactured by Schoelly Fiberoptic GmbH. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 25-day FDA review.

K143221 · Schoelly Fiberoptic GmbH · General & Plastic Surgery device
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Dec 2014
Decision
25d
Days
Class 2
Risk

K143221 is an FDA 510(k) clearance for the Schoelly Laparoscope. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Schoelly Fiberoptic GmbH (Denzlingen, DE). The FDA issued a Cleared decision on December 5, 2014 after a review of 25 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 Schoelly Fiberoptic GmbH devices

FDA 510(k) Submission Details - K143221

510(k) Number K143221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date December 05, 2014
Days to Decision 25 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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.

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All 790
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