Cleared Traditional

K994015 - ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

K994015 is an FDA 510(k) clearance for ACCUBLADE (ACS MODEL), manufactured by Surgin Surgical Instrumentation, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K994015 · Surgin Surgical Instrumentation, Inc. · Ophthalmic device
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Mar 2000
Decision
110d
Days
Class 1
Risk

K994015 is an FDA 510(k) clearance for the ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on March 15, 2000 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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 Surgin Surgical Instrumentation, Inc. devices

FDA 510(k) Submission Details - K994015

510(k) Number K994015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date March 15, 2000
Days to Decision 110 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 110d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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 - HNO Keratome, Ac-powered

All 71
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K994015.
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K001144 · Lasersight Technologies, Inc. · May 2000
BLADEWORKS MICROKERATOME BLADE
K993225 · Blade Works, Inc. · Mar 2000
MSP M/K BLADE
K993122 · Medical Sterile Products, Inc. · Mar 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
K993190 · Surgical Instrument Systems (Sis), Ltd. · Feb 2000
ULTRASHAPER KERATOME
K990227 · Lasersight Technologies, Inc. · Jan 2000
RICROKERATOME BLADE
K992978 · Surgistar, Inc. · Nov 1999