Cleared Traditional

K801609 - MADDOX LENS SPATULA CAT. #7245

K801609 is an FDA 510(k) clearance for MADDOX LENS SPATULA CAT. #7245, manufactured by Edward Weck, Inc.. The device is a Class 1 Ophthalmic device with product code HND cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K801609 · Edward Weck, Inc. · Ophthalmic device
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Aug 1980
Decision
29d
Days
Class 1
Risk

K801609 is an FDA 510(k) clearance for the MADDOX LENS SPATULA CAT. #7245. Classified as Spatula, Ophthalmic (product code HND), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 29 days - a notably fast clearance 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: 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K801609

510(k) Number K801609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date August 13, 1980
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

HND Device Classification - Class 1, General Controls

Product Code HND Spatula, 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 - HND Spatula, Ophthalmic

Devices cleared under the same product code (HND) and FDA review panel - the closest regulatory comparables to K801609.
THORNTON TITANIUM SILVER SPATULA
K863990 · Keeler Instruments, Inc. · Oct 1986
ANIS IRRIGATING SPATULA
K810937 · American V. Mueller · May 1981
MCCULLEY CONTINUOUS SUTURE TIGHTNER
K801608 · Edward Weck, Inc. · Aug 1980
SPATULA'S #'S 7618,7248,7240,7242,5108
K791983 · Edward Weck, Inc. · Oct 1979
CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM
K761253 · Edward Weck, Inc. · Dec 1976