Cleared Traditional

K800647 - NORSEN DEBRIDER

K800647 is the FDA 510(k) clearance for NORSEN DEBRIDER by Medline Industries, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEN) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K800647 · Medline Industries, Inc. · General & Plastic Surgery device
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Apr 1980
Decision
23d
Days
Class 1
Risk

K800647 is an FDA 510(k) clearance for the NORSEN DEBRIDER. Classified as Forceps, General & Plastic Surgery (product code GEN), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 23 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K800647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1980
Decision Date April 16, 1980
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEN Forceps, General & Plastic Surgery
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 - GEN Forceps, General & Plastic Surgery

All 53
Devices cleared under the same product code (GEN) and FDA review panel - the closest regulatory comparables to K800647.
RETRIEVAL FORCEPS W/RATTOOTHED JAWS
K820970 · Mill-Rose Laboratory · Apr 1982
BIOPSY FORCEPS W/OVAL CUPS
K820972 · Mill-Rose Laboratory · Apr 1982
BIOPSY FORCEPS W/OVAL CUP & NEEDLE
K820980 · Mill-Rose Laboratory · Apr 1982
CASTROVIEJO VASCULAR NEEDLEHOLDER 538425
K792309 · Edward Weck, Inc. · Nov 1979
VASCULAR FORCEPS & CLAMPS
K791987 · Edward Weck, Inc. · Oct 1979
C RING CLINCHER
K781446 · Orthopedic Equipment Co., Inc. · Sep 1978