Cleared Traditional

K834193 - JAKOBI SURG. INSTRUMENTS #2 70/71

K834193 is an FDA 510(k) clearance for JAKOBI SURG. INSTRUMENTS #2 70/71, manufactured by Imm Enterprises , Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K834193 · Imm Enterprises , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1984
Decision
81d
Days
Class 2
Risk

K834193 is an FDA 510(k) clearance for the JAKOBI SURG. INSTRUMENTS #2 70/71. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 - K834193

510(k) Number K834193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date February 10, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
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: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 187
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K834193.
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984
DRESSING CHANGE TRAY
K841123 · Medcare Products · Apr 1984
VANTAGE E
K841156 · American Sterilizer Co. · Apr 1984
PRO-GUARD
K830739 · Surgicot, Inc. · Mar 1983
EAGLE STERISET
K823902 · American Sterilizer Co. · Jan 1983
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982