Cleared Traditional

K873853 - DISPOSABLE INFUSION CANNULA 0045-1/2/3 ...

K873853 is the FDA 510(k) clearance for DISPOSABLE INFUSION CANNULA 0045-1/2/3 ... by Advanced Surgical Products, Inc.. It is a Class 1 Ophthalmic device (product code HMX) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K873853 · Advanced Surgical Products, Inc. · Ophthalmic device
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Mar 1988
Decision
167d
Days
Class 1
Risk

K873853 is an FDA 510(k) clearance for the DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on March 7, 1988 after a review of 167 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Surgical Products, Inc. devices

Submission Details

510(k) Number K873853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1987
Decision Date March 07, 1988
Days to Decision 167 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
57d slower than avg
Panel avg: 110d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HMX Cannula, Ophthalmic

All 37
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K873853.
PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE
K874999 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA
K875002 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE PUPIL CENTERING CANNULA
K875003 · Advanced Surgical Products, Inc. · Apr 1988
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA
K871605 · Advanced Surgical Products, Inc. · Jun 1987
OPHTHALMIC CANNULA
K872151 · Pharmacia, Inc. · Jun 1987
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
K854506 · Storz Instrument Co. · Feb 1986