Cleared Traditional

K091462 - SPECTRA MEDICAL SAFETY SCAPEL

K091462 is an FDA 510(k) clearance for SPECTRA MEDICAL SAFETY SCAPEL, manufactured by Spectra, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDZ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K091462 · Spectra, Inc. · General & Plastic Surgery device
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Dec 2009
Decision
211d
Days
Class 1
Risk

K091462 is an FDA 510(k) clearance for the SPECTRA MEDICAL SAFETY SCAPEL. Classified as Handle, Scalpel (product code GDZ), Class I - General Controls.

Submitted by Spectra, Inc. (Wilmington, US). The FDA issued a Cleared decision on December 15, 2009 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K091462

510(k) Number K091462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2009
Decision Date December 15, 2009
Days to Decision 211 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 115d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

GDZ Device Classification - Class 1, General Controls

Product Code GDZ Handle, Scalpel
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 Consultant

Spectra Medical Devices, Inc.
Kathy Dassler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GDZ Handle, Scalpel

All 13
Devices cleared under the same product code (GDZ) and FDA review panel - the closest regulatory comparables to K091462.
SCALPEL HANDLE
K890242 · Kinetic Medical Products · Jan 1989
BEAVER(R) HANDLE
K884512 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1988
P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
K863951 · Precision Surgical Industries, Inc. · Oct 1986
THE S. CORDERO STYLUS
K863808 · S. Cordero Co. · Oct 1986
KEISEI HANDLES FOR SURGICAL BLADES
K863212 · Keisei Medical Industrial Co., Ltd. · Sep 1986
SCALPEL HANDLE #3 SS 410 OR 420
K852711 · The Huxley Instrument Corp. · Jul 1985
K091462 · SPECTRA MEDICAL SAFETY SCAPEL
Download PDF Spectra, Inc.