Cleared Traditional

K921833 - ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD

K921833 is an FDA 510(k) clearance for ENDOPATH ENDO-SURGERY PERCUTANEOUS CATH..., manufactured by Ethicon, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K921833 · Ethicon, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 1992
Decision
158d
Days
Class 2
Risk

K921833 is an FDA 510(k) clearance for the ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 158 days - an extended review cycle.

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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K921833

510(k) Number K921833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 16, 1992
Decision Date September 21, 1992
Days to Decision 158 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 129d · This submission: 158d
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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K921833.
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