Cleared Traditional

OPERATING SCISSORS 5&1/2 CURVED SHARP (K821113) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K821113 · Conphar, Inc. · General & Plastic Surgery device
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May 1982
Decision
17d
Days
Class 1
Risk

K821113 is an FDA 510(k) clearance for the OPERATING SCISSORS 5&1/2 CURVED SHARP. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by Conphar, Inc. (Walker, US). The FDA issued a Cleared decision on May 7, 1982 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 Conphar, Inc. devices

Submission Details

510(k) Number K821113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date May 07, 1982
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZT Cutter, 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 - FZT Cutter, Surgical

All 28
Devices cleared under the same product code (FZT) and FDA review panel - the closest regulatory comparables to K821113.
CONPHAR TONSIL SCISSORS
K821361 · Conphar, Inc. · May 1982
CONPHAR SCISSORS 4&AHALF SHARPSHARP
K821111 · Conphar, Inc. · May 1982
CONPHAR SCISSORS 4&1/2 SHARP BLUNT
K821112 · Conphar, Inc. · May 1982
OPERATING SCISSORS CURVED 6 & 1/2 SHARP
K821114 · Conphar, Inc. · May 1982
SCISSORS CURVED 4 & 1/2 SHARP
K821115 · Conphar, Inc. · May 1982
LISTER BANDAGE SCISSORS 5 & 1/2
K821116 · Conphar, Inc. · May 1982