Cleared Traditional

K834355 - MICRO FORCEPS

K834355 is an FDA 510(k) clearance for MICRO FORCEPS, manufactured by Jedmed Instrument Co.. The device is a Class 1 Ophthalmic device with 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

FDA 510(k) Submission Details - K834355

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.

HNR Device Classification - Class 1, General Controls

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 32
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K834355.
PHARMASEAL EYE PREP TRAY
K850119 · American Pharmaseal Div. Ahsc · May 1985
SHURE GRIP TYING FORCEPS
K844129 · Mentor O & O, Inc. · Nov 1984
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