Cleared Traditional

K980027 - PEREGRINE SHIELDED DIFFUSION PROBE

K980027 is the FDA 510(k) clearance for PEREGRINE SHIELDED DIFFUSION PROBE by Peregrine Surgical , Ltd.. It is a Class 2 Ophthalmic device (product code MPA) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K980027 · Peregrine Surgical , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
85d
Days
Class 2
Risk

K980027 is an FDA 510(k) clearance for the PEREGRINE SHIELDED DIFFUSION PROBE. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Peregrine Surgical , Ltd. (Doylestown, US). The FDA issued a Cleared decision on March 31, 1998 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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 K980027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1998
Decision Date March 31, 1998
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.