Cleared Traditional

K834171 - OP-CON SURG. INSTRUMENT #3

K834171 is an FDA 510(k) clearance for OP-CON SURG. INSTRUMENT #3, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K834171 · Imm Enterprises , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1984
Decision
135d
Days
Class 1
Risk

K834171 is an FDA 510(k) clearance for the OP-CON SURG. INSTRUMENT #3. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Imm Enterprises , Ltd. devices

FDA 510(k) Submission Details - K834171

510(k) Number K834171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date April 04, 1984
Days to Decision 135 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 131d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

KOA Device Classification - Class 1, General Controls

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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 - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 29
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K834171.
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
K851112 · The Huxley Instrument Corp. · Apr 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
K851113 · The Huxley Instrument Corp. · Apr 1985
WESTON RECTAL SNARE
K841387 · Imm Enterprises , Ltd. · May 1984
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
K834191 · Imm Enterprises , Ltd. · Mar 1984
JAKOBI SURG. INSTRUMENTS #3 21/22/24
K834192 · Imm Enterprises , Ltd. · Mar 1984
PROBES, VARIOUS
K841003 · Premier Dental Products Co. · Mar 1984