Cleared Traditional

K900963 - GS-4350 TROCAR ONLY, 5.5MM

K900963 is an FDA 510(k) clearance for GS-4350 TROCAR ONLY, manufactured by Solos Endoscopy, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FBM cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K900963 · Solos Endoscopy, Inc. · Gastroenterology & Urology device
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Apr 1990
Decision
50d
Days
Class 1
Risk

K900963 is an FDA 510(k) clearance for the GS-4350 TROCAR ONLY, 5.5MM. Classified as Cannula And Trocar, Suprapubic, Non-disposable (product code FBM), Class I - General Controls.

Submitted by Solos Endoscopy, Inc. (Norcross, US). The FDA issued a Cleared decision on April 18, 1990 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - the FDA gastroenterology and urology 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 Solos Endoscopy, Inc. devices

FDA 510(k) Submission Details - K900963

510(k) Number K900963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date April 18, 1990
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

FBM Device Classification - Class 1, General Controls

Product Code FBM Cannula And Trocar, Suprapubic, Non-disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5090
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 - FBM Cannula And Trocar, Suprapubic, Non-disposable

All 8
Devices cleared under the same product code (FBM) and FDA review panel - the closest regulatory comparables to K900963.
GS-4000 REDUCER SLEEVE, 11MM TO 5MM
K900955 · Solos Endoscopy, Inc. · Apr 1990
GS-4100 REDUCER SLEEVE, 5MM TO 3MM
K900961 · Solos Endoscopy, Inc. · Apr 1990
GS-4300 CANNULA AND TROCAR, 5.5MM
K900962 · Solos Endoscopy, Inc. · Apr 1990
CANNULA AND TROCAR, 11MM
K900964 · Solos Endoscopy, Inc. · Apr 1990
GS-4550 TROCAR ONLY, 11MM
K900965 · Solos Endoscopy, Inc. · Apr 1990