Cleared Traditional

K980400 - PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10

K980400 is an FDA 510(k) clearance for PVRS-PEREGRINE VITREORETINAL SCISSOR MO..., 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 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

FDA 510(k) Submission Details - K980400

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
Combination Product No
PCCP Authorized No
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.

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 K980400.
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
K990292 · Ophthalmic Consultants, Inc. · Nov 1999
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
K983797 · Dutch Ophthalmic USA, Inc. · Mar 1999
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
K980399 · Peregrine Surgical , Ltd. · Apr 1998
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488 · Storz Instrument Co. · Mar 1998
REUSABLE VITRECTOMY PROBE
K970670 · Altex Vision · May 1997
DISPOSABLE VITRECTOMY PROBE
K970673 · Altex Vision · May 1997