Cleared Traditional

K923689 - SURGISTAR BLADES

K923689 is an FDA 510(k) clearance for SURGISTAR BLADES, manufactured by Surgistar, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K923689 · Surgistar, Inc. · General & Plastic Surgery device
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Sep 1992
Decision
47d
Days
Class 1
Risk

K923689 is an FDA 510(k) clearance for the SURGISTAR BLADES. Classified as Scalpel, One-piece (product code GDX), Class I - General Controls.

Submitted by Surgistar, Inc. (Vista, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 47 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 Surgistar, Inc. devices

FDA 510(k) Submission Details - K923689

510(k) Number K923689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1992
Decision Date September 09, 1992
Days to Decision 47 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

GDX Device Classification - Class 1, General Controls

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 13
Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K923689.
ICAN CYLINDRICAL SPONGES
K914086 · Icn Pharmaceuticals, Inc. · Oct 1991
CCI CORNEAL SCARIFIER
K904505 · Buckman Co., Inc. · Apr 1991
1-CUT ACL GRAFT KNIFE
K905380 · Depuy, Inc. · Dec 1990
VESSEL LOOPS
K895682 · Applied Medical Technologies · Oct 1989
7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1
K851751 · Artiberia · Jun 1985
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541 · Imm Enterprises , Ltd. · Jan 1984