Cleared Traditional

MICRO CISE DIAMOND SCALPEL (K820730) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K820730 · CooperVision, Inc. · General & Plastic Surgery device

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Apr 1982

Decision

23d

Days

Class 1

Risk

K820730 is an FDA 510(k) clearance for the MICRO CISE DIAMOND SCALPEL. Classified as Scalpel, One-piece (product code GDX), Class I - General Controls.

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on April 9, 1982 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 CooperVision, Inc. devices

Submission Details

510(k) Number	K820730 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 1982
Decision Date	April 09, 1982
Days to Decision	23 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

92d faster than avg

Panel avg: 115d · This submission: 23d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	GDX Scalpel, One-piece
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 - GDX Scalpel, One-piece

All 25

Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K820730.

1-CUT ACL GRAFT KNIFE

K905380 · Depuy, Inc. · Dec 1990

STERILE DISPOSABLE KNIFE

K790259 · Intermedics, Inc. · Feb 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.