Cleared Traditional

K961182 - 3D SCOPE

K961182 is an FDA 510(k) clearance for 3D SCOPE, manufactured by Oktas. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K961182 · Oktas · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jul 1996
Decision
115d
Days
Class 2
Risk

K961182 is an FDA 510(k) clearance for the 3D SCOPE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Oktas (Westborough, US). The FDA issued a Cleared decision on July 19, 1996 after a review of 115 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Oktas devices

FDA 510(k) Submission Details - K961182

510(k) Number K961182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1996
Decision Date July 19, 1996
Days to Decision 115 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K961182.
AIRLIFT BALLOON RETRACTON SYSTEM
K962104 · Origin Medsystems, Inc. · Sep 1996
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
K960903 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
EXTRAHAND BALLOON RETRACTOR
K962005 · Origin Medsystems, Inc. · Aug 1996
SPECIMEN RETRIEVAL BAG
K962395 · Applied Medical Resources · Jul 1996
5MM ENDOSCOPE
K960637 · Origin Medsystems, Inc. · Jun 1996
GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005
K960562 · Conmedcorp · Apr 1996