Cleared Traditional

K890195 - JAMES SURGICAL SYSTEM J1000

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

K890195 · O.R. Specialties, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 37
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
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884557 · Advanced Surgical Products, Inc. · May 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300 · CooperVision, Inc. · Apr 1989
DREYER CURVED ENDOILLUMINATOR
K884556 · Advanced Surgical Products, Inc. · Feb 1989