Cleared Traditional

K971832 - IVALON PVA SURGICAL SPEAR

K971832 is an FDA 510(k) clearance for IVALON PVA SURGICAL SPEAR, manufactured by M-Pact Worldwide Management Corp.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K971832 · M-Pact Worldwide Management Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
73d
Days
Class 2
Risk

K971832 is an FDA 510(k) clearance for the IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, I.... Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by M-Pact Worldwide Management Corp. (Eudora, US). The FDA issued a Cleared decision on July 31, 1997 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4790 - 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 M-Pact Worldwide Management Corp. devices

FDA 510(k) Submission Details - K971832

510(k) Number K971832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1997
Decision Date July 31, 1997
Days to Decision 73 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
37d faster than avg
Panel avg: 110d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HOZ Device Classification - Class 2, Special Controls

Product Code HOZ Sponge, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4790
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 - HOZ Sponge, Ophthalmic

All 13
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K971832.
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · Deroyal Industries, Inc. · Sep 1997
VISI-SPEAR EYE SPONGE
K933872 · Visitec Co. · Dec 1993
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707 · Jedmed Instrument Co. · Apr 1991
VISI-SWAB OPHTALMIC SPONGE
K902750 · Visitec Co. · Jul 1990
VISI-SORB ABSORBANT STICK
K900786 · Visitec Co. · May 1990