Cleared Traditional

K852057 - ASCON SURGICAL INSTRUMENTS

K852057 is the FDA 510(k) clearance for ASCON SURGICAL INSTRUMENTS by Ascon Medical Instruments, Ltd.. It is a Class 1 Ophthalmic device (product code HNR) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K852057 · Ascon Medical Instruments, Ltd. · Ophthalmic device
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Jun 1985
Decision
49d
Days
Class 1
Risk

K852057 is an FDA 510(k) clearance for the ASCON SURGICAL INSTRUMENTS. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Ascon Medical Instruments, Ltd. (Westmont, US). The FDA issued a Cleared decision on June 27, 1985 after a review of 49 days - a notably fast clearance cycle.

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: 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 Ascon Medical Instruments, Ltd. devices

Submission Details

510(k) Number K852057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date June 27, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 110d · This submission: 49d
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 30
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K852057.
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
K864003 · Allergan, Inc. · Oct 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861141 · CooperVision, Inc. · Apr 1986
STORZ/MAZZACCO LENS FORCEP
K860915 · Storz Instrument Co. · Apr 1986
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS
K851791 · Artiberia · May 1985
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS
K851792 · Artiberia · May 1985
PHARMASEAL EYE PREP TRAY
K850119 · American Pharmaseal Div. Ahsc · May 1985