Cleared Traditional

HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT (K844551) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K844551 · Gobbs Medical, Inc. · Gastroenterology & Urology device
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Jan 1985
Decision
43d
Days
Class 1
Risk

K844551 is an FDA 510(k) clearance for the HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT. Classified as Forceps, Biopsy, Non-electric (product code FCL), Class I - General Controls.

Submitted by Gobbs Medical, Inc. (Palmer, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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: 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 Gobbs Medical, Inc. devices

Submission Details

510(k) Number K844551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date January 03, 1985
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCL Forceps, Biopsy, Non-electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.