Cleared Traditional

K895683 - BERNARD VESSEL APPROXIMATOR

K895683 is an FDA 510(k) clearance for BERNARD VESSEL APPROXIMATOR, manufactured by Applied Medical Technologies. The device is a Class 1 General & Plastic Surgery device with product code HRQ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K895683 · Applied Medical Technologies · General & Plastic Surgery device
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Oct 1989
Decision
33d
Days
Class 1
Risk

K895683 is an FDA 510(k) clearance for the BERNARD VESSEL APPROXIMATOR. Classified as Hemostat (product code HRQ), Class I - General Controls.

Submitted by Applied Medical Technologies (Independence, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: 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 Applied Medical Technologies devices

FDA 510(k) Submission Details - K895683

510(k) Number K895683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1989
Decision Date October 24, 1989
Days to Decision 33 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

HRQ Device Classification - Class 1, General Controls

Product Code HRQ Hemostat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - HRQ Hemostat

All 9
Devices cleared under the same product code (HRQ) and FDA review panel - the closest regulatory comparables to K895683.
SURGICAL HEMOSTATS
K890245 · Kinetic Medical Products · Jan 1989
HEMSTATS
K844152 · I M, Inc. · Nov 1984
SCANLAN VASCU-STATT II APPROXIMATOR
K841514 · Scanlan Intl., Inc. · Jun 1984
OP-CON SURG. INSTRUMENTS #11
K834175 · Imm Enterprises , Ltd. · Jan 1984
HEMOSTATS
K831797 · I M, Inc. · Jul 1983
VASCU-STATT APPROXIMATOR
K823694 · Scanlan Intl., Inc. · Jan 1983