Cleared Traditional

K844062 - FORCEPS & HAMOSTATS

K844062 is the FDA 510(k) clearance for FORCEPS & HAMOSTATS by I M, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K844062 · I M, Inc. · General & Plastic Surgery device
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Jan 1985
Decision
92d
Days
Class 1
Risk

K844062 is an FDA 510(k) clearance for the FORCEPS & HAMOSTATS. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all I M, Inc. devices

Submission Details

510(k) Number K844062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1984
Decision Date January 18, 1985
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEN Forceps, General & Plastic Surgery
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 - GEN Forceps, General & Plastic Surgery

All 53
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K844062.
MAGILL FORCEPS 1711-46 PCS. SS 410 OR 420
K851114 · The Huxley Instrument Corp. · Apr 1985
JUDD-AILLIS TISSUE FORCEPS 1820-118 PCS. SS 410/42
K851116 · The Huxley Instrument Corp. · Apr 1985
DISSECTING TWEEZER #283-72PCS. SS 410
K851170 · The Huxley Instrument Corp. · Apr 1985
DISPOSABLE GRASPING FORCEPS
K822491 · Van-Tec, Inc. · Sep 1982
ENT FORCEPS
K822278 · Kelleher Corp. · Aug 1982
ROCHESTER PEAN FORCEPS
K821248 · Conphar, Inc. · May 1982