Cleared Traditional

K913235 - DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH

K913235 is an FDA 510(k) clearance for DAVOL IMPLANT PORTS W/ATTACH HI PERF GR..., manufactured by Davol, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K913235 · Davol, Inc. · General Hospital
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Oct 1991
Decision
101d
Days
Class 2
Risk

K913235 is an FDA 510(k) clearance for the DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 31, 1991 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Davol, Inc. devices

FDA 510(k) Submission Details - K913235

510(k) Number K913235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1991
Decision Date October 31, 1991
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 481
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K913235.
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