Cleared Traditional

K980400 - PVRS-PEREGRINE VITREORETINAL SCISSOR MO...

K980400 is the FDA 510(k) clearance for PVRS-PEREGRINE VITREORETINAL SCISSOR MO... by Peregrine Surgical , Ltd.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980400 · Peregrine Surgical , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
87d
Days
Class 2
Risk

K980400 is an FDA 510(k) clearance for the PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10. 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 April 30, 1998 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Peregrine Surgical , Ltd. devices

Submission Details

510(k) Number K980400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1998
Decision Date April 30, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
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 34
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K980400.
UniVit HE, UniVit UHS
K212763 · Visioncare Devices, LLC · Aug 2022
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488 · Storz Instrument Co. · Mar 1998
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K964743 · Storz Instrument Co. · Feb 1997
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
K960061 · Storz Instrument Co. · Sep 1996
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
K954816 · Storz Instrument Co. · Mar 1996
STORZ MVS-3201 VITRECTOMY PROBE PACK
K953575 · Storz Instrument Co. · Sep 1995