Cleared Traditional

INFRA VISION IMAGING SYSTEM (K945297) - FDA 510(k) Clearance

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

K945297 · Gabriel Medical, Inc. · General & Plastic Surgery device
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Dec 1994
Decision
50d
Days
Class 2
Risk

K945297 is an FDA 510(k) clearance for the INFRA VISION IMAGING SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Gabriel Medical, Inc. (Lafayette, US). The FDA issued a Cleared decision on December 20, 1994 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gabriel Medical, Inc. devices

Submission Details

510(k) Number K945297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1994
Decision Date December 20, 1994
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 353
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K945297.
KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR
K946330 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KSEA STEINER ELECTROMECHANIC MORCELLATORT
K946213 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS
K946164 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K946023 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
K945751 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944299 · KARL STORZ Endoscopy-America, Inc. · Dec 1994