Cleared Traditional

K760791 - COOLEY ANGLED SCISSOR - 1MM PROBE POINT

K760791 is the FDA 510(k) clearance for COOLEY ANGLED SCISSOR - 1MM PROBE POINT by V. Mueller O.V. Baxter Healthcare Corp.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K760791 · V. Mueller O.V. Baxter Healthcare Corp. · Cardiovascular device
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Nov 1976
Decision
35d
Days
Class 1
Risk

K760791 is an FDA 510(k) clearance for the COOLEY ANGLED SCISSOR - 1MM PROBE POINT. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 11, 1976 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1976
Decision Date November 11, 1976
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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 - DWS Instruments, Surgical, Cardiovascular

All 35
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K760791.
AORTIC PUMP
K780567 · Ethicon, Inc. · Apr 1978
HUANG VEIN HOLDER, #21-8011
K771026 · Codman & Shurtleff, Inc. · Jun 1977
67-8006 DARLING-LINTON AORTIC TOURN.
K761161 · Codman & Shurtleff, Inc. · Dec 1976
SCISSOR - 1.5MM PROBE POINT, ANGLED
K760792 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976
CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP
K760645 · Pilling Co. · Sep 1976
CAROTID ARTERY CLAMP W/PILLING LMM
K760646 · Pilling Co. · Sep 1976