Cleared Traditional

K843371 - VALVOTOMY KNIFE

K843371 is an FDA 510(k) clearance for VALVOTOMY KNIFE, manufactured by Downs Surgical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code EMF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K843371 · Downs Surgical , Ltd. · General & Plastic Surgery device
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Oct 1984
Decision
58d
Days
Class 1
Risk

K843371 is an FDA 510(k) clearance for the VALVOTOMY KNIFE. Classified as Knife, Surgical (product code EMF), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Decata, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K843371

510(k) Number K843371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date October 25, 1984
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

EMF Device Classification - Class 1, General Controls

Product Code EMF Knife, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - EMF Knife, Surgical

All 10
Devices cleared under the same product code (EMF) and FDA review panel - the closest regulatory comparables to K843371.
VALTRAC (BAR) REMOVER DEVICE
K863752 · Davis & Geck, Inc. · Oct 1986
REUSABLE/DISPOSABLE AUTOPSY KNIFE SET
K863549 · Surgipath Medical Industries, Inc. · Sep 1986
27-210 PLASTER KNIFE (REINER)
K851784 · Artiberia · Jun 1985
H.R. JAKOBI SURG. INSTRUMENTS #11 38/67
K834184 · Imm Enterprises , Ltd. · Jan 1984
JAKOBI SURG. INSTR- #11 38/39/45/46/67
K834197 · Imm Enterprises , Ltd. · Jan 1984
CHANGING METHOD OF STERILITY RELEASE
K832368 · Devon Industries, Inc. · Oct 1983