Cleared Traditional

3DSEE (K951646) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951646 · Intl. Telepresence Corp. · General & Plastic Surgery device
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Oct 1995
Decision
177d
Days
Class 2
Risk

K951646 is an FDA 510(k) clearance for the 3DSEE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Intl. Telepresence Corp. (Boston, US). The FDA issued a Cleared decision on October 4, 1995 after a review of 177 days - an extended review 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. 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 Intl. Telepresence Corp. devices

Submission Details

510(k) Number K951646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date October 04, 1995
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K951646.
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
K943307 · Olympus America, Inc. · Dec 1995
AUTO SUTURE SUTURE CLOSURE
K954853 · United States Surgical, A Division of Tyco Healthc · Dec 1995
MODIFIED VERSAPORT
K954108 · United States Surgical, A Division of Tyco Healthc · Oct 1995
FASCIA CLOSURE DEVICE
K954011 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
KSEA EXTRACTION BAG
K953549 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
BIPOLAR COAGULATING FORCEPS
K953509 · KARL STORZ Endoscopy-America, Inc. · Aug 1995