Cleared Traditional

K912544 - BIPOLAR FORCEPS

K912544 is the FDA 510(k) clearance for BIPOLAR FORCEPS by Everest Medical Corp.. It is a Class 2 Cardiovascular device (product code MAV) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K912544 · Everest Medical Corp. · Cardiovascular device
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Jun 1991
Decision
14d
Days
Class 2
Risk

K912544 is an FDA 510(k) clearance for the BIPOLAR FORCEPS. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Everest Medical Corp. (Minneapolis, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Everest Medical Corp. devices

Submission Details

510(k) Number K912544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date June 24, 1991
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 30
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K912544.
MONARCH(TM) INFLATION SYRINGE
K913994 · Merit Medical Systems, Inc. · Feb 1992
CORDIS INFLATOR DEVICE
K912644 · Cordis Corp. · Sep 1991
MEDFLATOR INFLATION SYSTEM
K910958 · Medex, Inc. · Jul 1991
DISPOSABLE INFLATION GAUGE
K902695 · Cook Urological, Inc. · Dec 1990
INFLATION/DEFLATION DEVICE
K904394 · Boston Scientific Corp · Dec 1990
ACS INDEFLATOR XX
K896849 · Advanced Cardiovascular Systems, Inc. · Feb 1990