Cleared Traditional

K841977 - 5MM DOUGLE EDGE RING CURETTE

K841977 is an FDA 510(k) clearance for 5MM DOUGLE EDGE RING CURETTE, manufactured by Stainless Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTZ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K841977 · Stainless Mfg., Inc. · General & Plastic Surgery device
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Jun 1984
Decision
36d
Days
Class 1
Risk

K841977 is an FDA 510(k) clearance for the 5MM DOUGLE EDGE RING CURETTE. Classified as Instrument, Cutting, Orthopedic (product code HTZ), Class I - General Controls.

Submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 36 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 Stainless Mfg., Inc. devices

FDA 510(k) Submission Details - K841977

510(k) Number K841977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 19, 1984
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

HTZ Device Classification - Class 1, General Controls

Product Code HTZ Instrument, Cutting, Orthopedic
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 - HTZ Instrument, Cutting, Orthopedic

All 13
Devices cleared under the same product code (HTZ) and FDA review panel - the closest regulatory comparables to K841977.
RETROGRADE KNIFE 4MM & 5MM
K841974 · Stainless Mfg., Inc. · Jun 1984
ROSETTE KNIFE 4MM
K841975 · Stainless Mfg., Inc. · Jun 1984
HOOK KNIFE 4MM & 5MM
K841976 · Stainless Mfg., Inc. · Jun 1984
LATERAL RELEASE KNIFE 5MM & 7MM
K841978 · Stainless Mfg., Inc. · Jun 1984
MENISCOTOME 4MM & 5MM
K841982 · Stainless Mfg., Inc. · Jun 1984
MICRO OSCILLATING SAW
K771915 · American Sterilizer Co. · Oct 1977