Cleared Traditional

K772021 - TRC STAINLESS STEEL SAFETY SPRING GUIDES (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K772021 · Usci, Div. C.R. Bard, Inc. · Radiology device
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Nov 1977
Decision
7d
Days
Class 2
Risk

K772021 is an FDA 510(k) clearance for the TRC STAINLESS STEEL SAFETY SPRING GUIDES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Usci, Div. C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1330 - the FDA radiology and imaging software oversight 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 Usci, Div. C.R. Bard, Inc. devices

Submission Details

510(k) Number K772021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1977
Decision Date November 02, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 107d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 Radiology devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 762
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