Cleared Special

K131688 - NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K131688 · Neosurgical, Ltd. · General & Plastic Surgery device
Jul 2013
Decision
38d
Days
Class 2
Risk

K131688 is an FDA 510(k) clearance for the NEOCLOSE HASSON, NEOCLOSE UNIVERSAL. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Neosurgical, Ltd. (Galway, IE). The FDA issued a Cleared decision on July 18, 2013 after a review of 38 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.

Submission Details

510(k) Number K131688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2013
Decision Date July 18, 2013
Days to Decision 38 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 132d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 62
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K131688.
C-Lant Port
K252714 · Vigor Medical Technologies , Ltd. · Feb 2026
Universal Seal (5-12 mm)
K253978 · Intuitive Surgical, Inc. · Feb 2026
1688 4K Camera System with Advanced Imaging Modality
K260185 · Stryker Endoscopy · Feb 2026
Saberscope™ Laparoscope (SAS-A-536L)
K260177 · Xenocor, Inc. · Feb 2026
Medical Shaver System (Morcellator) (YSB-IIIA)
K251923 · Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · Jan 2026
Pneumo Dissector Hook
K252957 · Ab Medica Sas · Jan 2026