Cleared Traditional

K861947 - SURGICAL KNIFE

K861947 is the FDA 510(k) clearance for SURGICAL KNIFE by Sharpoint, Inc.. It is a Class 1 General & Plastic Surgery device (product code EMF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K861947 · Sharpoint, Inc. · General & Plastic Surgery device
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Jun 1986
Decision
17d
Days
Class 1
Risk

K861947 is an FDA 510(k) clearance for the SURGICAL KNIFE. Classified as Knife, Surgical (product code EMF), Class I - General Controls.

Submitted by Sharpoint, Inc. (Reading, US). The FDA issued a Cleared decision on June 6, 1986 after a review of 17 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 Sharpoint, Inc. devices

Submission Details

510(k) Number K861947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1986
Decision Date June 06, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K861947.
MICROSURGICAL KNIVES
K890217 · Kinetic Medical Products · Jan 1989
VAN-TEC ENDOPYELOTOMY KNIFE
K880094 · Van-Tec, Inc. · Feb 1988
VALTRAC (BAR) REMOVER DEVICE
K863752 · Davis & Geck, Inc. · Oct 1986
27-210 PLASTER KNIFE (REINER)
K851784 · Artiberia · Jun 1985
VALVOTOMY KNIFE
K843371 · Downs Surgical , Ltd. · Oct 1984
H.R. JAKOBI SURG. INSTRUMENTS #11 38/67
K834184 · Imm Enterprises , Ltd. · Jan 1984