Cleared Traditional

ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR (K960301) - FDA 510(k) Clearance

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

K960301 · Del Medical Systems Corp. · General & Plastic Surgery device
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Sep 1996
Decision
252d
Days
Class 2
Risk

K960301 is an FDA 510(k) clearance for the ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Del Medical Systems Corp. (Valhalla, US). The FDA issued a Cleared decision on September 30, 1996 after a review of 252 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 Del Medical Systems Corp. devices

Submission Details

510(k) Number K960301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date September 30, 1996
Days to Decision 252 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
137d slower than avg
Panel avg: 115d · This submission: 252d
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 354
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K960301.
TROCAR CANNULA
K963115 · United States Surgical, A Division of Tyco Healthc · Feb 1997
TANDEMRX
K970054 · Boston Scientific Corp · Feb 1997
ETHICON ENDOSUTURE SYSTEM
K963329 · Ethicon, Inc. · Oct 1996
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
K960903 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
MODIFIED HAND INSTRUMENT DEVICES
K960748 · United States Surgical, A Division of Tyco Healthc · Apr 1996
AUTO SUTURE SUTURE CLOSURE
K954853 · United States Surgical, A Division of Tyco Healthc · Dec 1995