Cleared Traditional

K834175 - OP-CON SURG. INSTRUMENTS #11

K834175 is an FDA 510(k) clearance for OP-CON SURG. INSTRUMENTS #11, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code HRQ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K834175 · Imm Enterprises , Ltd. · General & Plastic Surgery device
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Jan 1984
Decision
67d
Days
Class 1
Risk

K834175 is an FDA 510(k) clearance for the OP-CON SURG. INSTRUMENTS #11. Classified as Hemostat (product code HRQ), 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

FDA 510(k) Submission Details - K834175

510(k) Number K834175 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.

HRQ Device Classification - Class 1, General Controls

Product Code HRQ Hemostat
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 - HRQ Hemostat

All 9
Devices cleared under the same product code (HRQ) and FDA review panel - the closest regulatory comparables to K834175.
SURGICAL HEMOSTATS
K890245 · Kinetic Medical Products · Jan 1989
HEMSTATS
K844152 · I M, Inc. · Nov 1984
SCANLAN VASCU-STATT II APPROXIMATOR
K841514 · Scanlan Intl., Inc. · Jun 1984
HEMOSTATS
K831797 · I M, Inc. · Jul 1983
VASCU-STATT APPROXIMATOR
K823694 · Scanlan Intl., Inc. · Jan 1983
VARIOUS TYPES OF TONSILS HEMOSTATS
K822263 · Kelleher Corp. · Aug 1982