Cleared Traditional

K880952 - PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS

K880952 is an FDA 510(k) clearance for PRISMA DISPOSABLE 19 AND 20 GAUGE SCLER..., manufactured by Advanced Surgical Products, Inc.. The device is a Class 2 Ophthalmic device with product code LXP cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K880952 · Advanced Surgical Products, Inc. · Ophthalmic device
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May 1988
Decision
67d
Days
Class 2
Risk

K880952 is an FDA 510(k) clearance for the PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS. Classified as Plug, Scleral (product code LXP), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4155 - 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 Advanced Surgical Products, Inc. devices

FDA 510(k) Submission Details - K880952

510(k) Number K880952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date May 13, 1988
Days to Decision 67 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 110d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXP Device Classification - Class 2, Special Controls

Product Code LXP Plug, Scleral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4155
Definition Intended To Provide Temporary Closure Of A Scleral Incision During An Ophthalmic Procedure.
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 - LXP Plug, Scleral

Devices cleared under the same product code (LXP) and FDA review panel - the closest regulatory comparables to K880952.
SCLERAL PLUGS, 19 AND 20 GAUGE
K990872 · Ophthalmic Consultants, Inc. · Jul 1999
VISITEC SCLERAL PLUG
K945114 · Visitec Co. · Feb 1995
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
K880953 · Advanced Surgical Products, Inc. · May 1988
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K871604 · Advanced Surgical Products, Inc. · Jun 1987
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
K854507 · Storz Instrument Co. · Feb 1986
SCLERAL PLUG
K831193 · Medical Instrument Development Laboratories, Inc. · Jun 1983