Cleared Traditional

K843628 - HOTIP HEMOSTATIC PROBE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843628 · Trimedyne, Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
424d
Days
Class 2
Risk

K843628 is an FDA 510(k) clearance for the HOTIP HEMOSTATIC PROBE. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Walker, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4810 - the FDA gastroenterology and urology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Trimedyne, Inc. devices

Submission Details

510(k) Number K843628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1984
Decision Date November 12, 1985
Days to Decision 424 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 130d · This submission: 424d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNK Laser For Gastro-urology Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
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 Gastroenterology & Urology devices follow this clearance model.