Cleared Traditional

K940391 - PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE

K940391 is an FDA 510(k) clearance for PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE, manufactured by Peregrine Surgical , Ltd.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K940391 · Peregrine Surgical , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
133d
Days
Class 2
Risk

K940391 is an FDA 510(k) clearance for the PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Peregrine Surgical , Ltd. (Doylestown, US). The FDA issued a Cleared decision on June 8, 1994 after a review of 133 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 Peregrine Surgical , Ltd. devices

FDA 510(k) Submission Details - K940391

510(k) Number K940391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date June 08, 1994
Days to Decision 133 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
23d slower than avg
Panel avg: 110d · This submission: 133d
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 90
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K940391.
INFINITECH SOFT TIP FLUTE NEEDLE
K946181 · Surgical Technologies, Inc. · Mar 1995
MICRODRIVE
K934600 · Medical Instrument Development Laboratories, Inc. · Jul 1994
NIDEK MODEL VT-4000, MODIFICATION
K936302 · Nidek, Inc. · Jul 1994
SUPRA-VIT(TM)
K932669 · Medical Instrument Development Laboratories, Inc. · Jun 1994
STORZ FIBEROPTIC PICK MANIPULATOR
K933907 · Storz Instrument Co. · Mar 1994
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
K932668 · Synergetics, Inc. · Feb 1994