Cleared Traditional

K852706 - VERSABLADE

K852706 is an FDA 510(k) clearance for VERSABLADE, manufactured by Alphamedix, Inc.. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K852706 · Alphamedix, Inc. · Ophthalmic device
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Nov 1985
Decision
131d
Days
Class 1
Risk

K852706 is an FDA 510(k) clearance for the VERSABLADE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Alphamedix, Inc. (Cupertino, US). The FDA issued a Cleared decision on November 4, 1985 after a review of 131 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 Alphamedix, Inc. devices

FDA 510(k) Submission Details - K852706

510(k) Number K852706 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 26, 1985
Decision Date November 04, 1985
Days to Decision 131 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 110d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

HNN Device Classification - Class 1, General Controls

Product Code HNN Knife, 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 - HNN Knife, Ophthalmic

All 23
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K852706.
RUBY & SAPPHIRE BLADE HOLDER
K861748 · Keeler Instruments, Inc. · Jun 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · Storz Instrument Co. · May 1986
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · Storz Instrument Co. · Mar 1986
SMARTKNIFE SYSTEM
K853063 · CooperVision, Inc. · Nov 1985
STORZ DIAMOND KNIFE
K853403 · Storz Instrument Co. · Nov 1985
37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN
K851790 · Artiberia · May 1985