Cleared Traditional

K890195 - JAMES SURGICAL SYSTEM J1000

K890195 is an FDA 510(k) clearance for JAMES SURGICAL SYSTEM J1000, manufactured by O.R. Specialties, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K890195 · O.R. Specialties, Inc. · Ophthalmic device
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Aug 1989
Decision
197d
Days
Class 2
Risk

K890195 is an FDA 510(k) clearance for the JAMES SURGICAL SYSTEM J1000. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 197 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 O.R. Specialties, Inc. devices

FDA 510(k) Submission Details - K890195

510(k) Number K890195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date August 03, 1989
Days to Decision 197 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 110d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 93
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K890195.
I/A HANDPIECE
K896754 · Advanced Surgical Products, Inc. · Jan 1990
MULTI-USE I/A HANDPIECE
K896305 · Advanced Surgical Products, Inc. · Dec 1989
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K894278 · Storz Instrument Co. · Aug 1989
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
K891601 · Mira, Inc. · May 1989
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884557 · Advanced Surgical Products, Inc. · May 1989
SURG-E-TROL SYSTEM I AND SYSTEM II
K890622 · Mentor O & O, Inc. · May 1989