Cleared Traditional

K831661 - DISPOSABLE SCISSORS

K831661 is an FDA 510(k) clearance for DISPOSABLE SCISSORS, manufactured by Medcare Products. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K831661 · Medcare Products · General & Plastic Surgery device
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Aug 1983
Decision
94d
Days
Class 1
Risk

K831661 is an FDA 510(k) clearance for the DISPOSABLE SCISSORS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Medcare Products (Mchenry, US). The FDA issued a Cleared decision on August 25, 1983 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcare Products devices

FDA 510(k) Submission Details - K831661

510(k) Number K831661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date August 25, 1983
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

KDC Device Classification - Class 1, General Controls

Product Code KDC Instrument, Surgical, Disposable
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 - KDC Instrument, Surgical, Disposable

All 31
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K831661.
DISPOSABLE NEEDLE HOLDER
K831665 · Medcare Products · Sep 1983
DISPOSABLE FLOOR INSTRUMENTS
K831911 · Ormed Mfg., Inc. · Sep 1983
SAFETY PINS & RUBBER BANDS
K831915 · Ormed Mfg., Inc. · Sep 1983
DISPOSABLE HEMOSTAT (STRAIGHT&CURVED
K831662 · Medcare Products · Jul 1983
DISPOSABLE SCALPELS
K831798 · I M, Inc. · Jul 1983
DEVO'N LOOPS
K830248 · Devon Industries, Inc. · Mar 1983