Cleared Traditional

K760700 - SILASTIC BRAND G7-2090A

K760700 is an FDA 510(k) clearance for SILASTIC BRAND G7-2090A, manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K760700 · Dow Corning Corp. Healthcare Industries Materials · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1976
Decision
41d
Days
Class 1
Risk

K760700 is an FDA 510(k) clearance for the SILASTIC BRAND G7-2090A. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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 Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K760700

510(k) Number K760700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1976
Decision Date November 02, 1976
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 49
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K760700.
ROUND SILICONE DRAIN
K782028 · Davol, Inc. · Dec 1978
FLAT SILICONE DRAIN
K782026 · Davol, Inc. · Dec 1978
PORTABLE CLOSED WOUND SUCTION EVACUATOR
K780848 · Biomet, Inc. · Aug 1978
ARGYLE SUCTION CONTROL KIT
K760601 · Sherwood Medical Co. · Nov 1976
YASARGIL SUCTION TUBE - SMALL
K760745 · Codman & Shurtleff, Inc. · Nov 1976
YASARGIL SUCTION TUBE - LARGE
K760746 · Codman & Shurtleff, Inc. · Nov 1976