Cleared Traditional

K771448 - STERILE SUTURE REMOVAL KIT

K771448 is an FDA 510(k) clearance for STERILE SUTURE REMOVAL KIT, manufactured by Premium Plastics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K771448 · Premium Plastics, Inc. · General & Plastic Surgery device
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Sep 1977
Decision
35d
Days
Class 1
Risk

K771448 is an FDA 510(k) clearance for the STERILE SUTURE REMOVAL KIT. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Premium Plastics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 6, 1977 after a review of 35 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 Premium Plastics, Inc. devices

FDA 510(k) Submission Details - K771448

510(k) Number K771448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1977
Decision Date September 06, 1977
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, 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 - KDD Kit, Surgical Instrument, Disposable

All 31
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K771448.
SUTURE REMOVAL SET CAT.#906
K802019 · Pollak (Intl.), Ltd. · Sep 1980
INSTRUMENT AND ACCESSORY KIT
K780488 · American Hospital Supply Corp. · Apr 1978
URINE SAMPLE KIT
K780336 · American Hospital Supply Corp. · Apr 1978
MAJOR SUTURE REMOVAL TRAY
K770149 · Pharmaseal Div., Baxter Healthcare Corp. · Feb 1977