Cleared Traditional

K834541 - H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48

K834541 is the FDA 510(k) clearance for H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 by Imm Enterprises , Ltd.. It is a Class 1 General & Plastic Surgery device (product code GDX) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K834541 · Imm Enterprises , Ltd. · General & Plastic Surgery device
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Jan 1984
Decision
67d
Days
Class 1
Risk

K834541 is an FDA 510(k) clearance for the H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48. Classified as Scalpel, One-piece (product code GDX), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Imm Enterprises , Ltd. devices

Submission Details

510(k) Number K834541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date January 27, 1984
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDX Scalpel, One-piece
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - GDX Scalpel, One-piece

Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K834541.
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