Cleared Traditional

K834195 - JAKOBI SURG. INSTRUMENTS #11 11/13/14

K834195 is an FDA 510(k) clearance for JAKOBI SURG. INSTRUMENTS #11 11/13/14, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GES cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K834195 · Imm Enterprises , Ltd. · General & Plastic Surgery device
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Jan 1984
Decision
67d
Days
Class 1
Risk

K834195 is an FDA 510(k) clearance for the JAKOBI SURG. INSTRUMENTS #11 11/13/14. Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Walker, 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

FDA 510(k) Submission Details - K834195

510(k) Number K834195 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

GES Device Classification - Class 1, General Controls

Product Code GES Blade, Scalpel
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 - GES Blade, Scalpel

All 10
Devices cleared under the same product code (GES) and FDA review panel - the closest regulatory comparables to K834195.
FASCIA CUTTER
K834514 · Stryker Corp. · Mar 1984
H.R. JAKOBI SURG. INSTRUMENTS #11 27/37
K834182 · Imm Enterprises , Ltd. · Jan 1984
JAKOBI SURG. INSTRUMENTS #1 19/10/26
K834194 · Imm Enterprises , Ltd. · Jan 1984
BLADE, 20 ANGLE/MICRO BLADE HOLDER
K781716 · Edward Weck, Inc. · Oct 1978
SURGICAL BLADES
K761322 · Richard-Allan Medical Ind., Inc. · Jan 1977