Cleared Traditional

K832047 - STERILE SUTURE REMOVAL SET

K832047 is an FDA 510(k) clearance for STERILE SUTURE REMOVAL SET, manufactured by Ormed Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K832047 · Ormed Mfg., Inc. · General & Plastic Surgery device
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Sep 1983
Decision
80d
Days
Class 1
Risk

K832047 is an FDA 510(k) clearance for the STERILE SUTURE REMOVAL SET. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Ormed Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 80 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 Ormed Mfg., Inc. devices

FDA 510(k) Submission Details - K832047

510(k) Number K832047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1983
Decision Date September 12, 1983
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 30
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K832047.
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984
VYGON THORACIC DRAINAGE-VARIOUS #'S
K832628 · Exco, Inc. · Jan 1984
STERILE DISP. INSTRUMENT TRAYS
K831841 · E.M. Adams · Dec 1983
FIRST AID KITS
K831795 · I M, Inc. · Sep 1983
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981
LARGE WOUND DRESSING KIT
K803119 · American Medical Disposable, Inc. · Dec 1980