Cleared Traditional

K834355 - MICRO FORCEPS

K834355 is the FDA 510(k) clearance for MICRO FORCEPS by Jedmed Instrument Co.. It is a Class 1 Ophthalmic device (product code HNR) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K834355 · Jedmed Instrument Co. · Ophthalmic device
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Mar 1984
Decision
94d
Days
Class 1
Risk

K834355 is an FDA 510(k) clearance for the MICRO FORCEPS. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Jedmed Instrument Co. devices

Submission Details

510(k) Number K834355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date March 16, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 110d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNR Forceps, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HNR Forceps, Ophthalmic

All 29
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K834355.
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS
K851792 · Artiberia · May 1985
PHARMASEAL EYE PREP TRAY
K850119 · American Pharmaseal Div. Ahsc · May 1985
ROOTMAN ORBITAL SURGERY INSTRUMENT SET
K842697 · Downs Surgical , Ltd. · Aug 1984
MICROSURGICAL INSTRUMENTS
K823174 · Concept, Inc. · Nov 1982
ANIS LENS IMPLANT FORCEPS #2
K811658 · American V. Mueller · Jun 1981
FISHER-PICKERING INTRAOCULAR EYE MAGNET
K803194 · Storz Instrument Co. · Feb 1981