Cleared Traditional

K791981 - SWAN KNIFE NEEDLE 1.5MM CAT # 1170

K791981 is an FDA 510(k) clearance for SWAN KNIFE NEEDLE 1.5MM CAT # 1170, manufactured by Edward Weck, Inc.. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K791981 · Edward Weck, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1979
Decision
9d
Days
Class 1
Risk

K791981 is an FDA 510(k) clearance for the SWAN KNIFE NEEDLE 1.5MM CAT # 1170. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979 after a review of 9 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 - K791981

510(k) Number K791981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1979
Decision Date October 04, 1979
Days to Decision 9 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
101d faster than avg
Panel avg: 110d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

HNN Device Classification - Class 1, General Controls

Product Code HNN Knife, 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 - HNN Knife, Ophthalmic

All 21
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K791981.
MICROSURGERY KNIFE
K820618 · Visitec Co. · Apr 1982
PILLING K KNIFE
K812918 · Narco Scientific · Nov 1981
TOME'S #'S 1221,1222,1223,1314,6640,6642
K791980 · Edward Weck, Inc. · Oct 1979
MICROSURGICAL KNIVES, 20, 30, 45
K781465 · Codman & Shurtleff, Inc. · Sep 1978
DISSECTOR, TROUTMAN CORNEAL
K760186 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976
KNIFE, TROUTMAN CORNEAL SMALL
K760187 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976