Cleared Traditional

K922355 - POLLY'S VITREOUS SCISSORS J-225-S

K922355 is an FDA 510(k) clearance for POLLY'S VITREOUS SCISSORS J-225-S, 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 91-day FDA review.

K922355 · O.R. Specialties, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
91d
Days
Class 2
Risk

K922355 is an FDA 510(k) clearance for the POLLY'S VITREOUS SCISSORS J-225-S. 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 18, 1992 after a review of 91 days - within the typical 510(k) review window.

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 - K922355

510(k) Number K922355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1992
Decision Date August 18, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
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 K922355.
NIDEK MODEL VST-4000
K924353 · Nidek, Inc. · Mar 1993
MID LABS, INC. VIT MATE
K924222 · Medical Instrument Development Laboratories, Inc. · Jan 1993
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
K924604 · Storz Instrument Co. · Nov 1992
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
K921758 · Storz Instrument Co. · Jul 1992
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
K921460 · Storz Instrument Co. · Jul 1992
DISPOSABLE POSTERIOR MICROSCISSORS
K920718 · Storz Instrument Co. · May 1992