Cleared Traditional

MAYO-HEGAR NEEDLE HOLDER (K821289) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K821289 · Conphar, Inc. · General & Plastic Surgery device
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Jun 1982
Decision
30d
Days
Class 1
Risk

K821289 is an FDA 510(k) clearance for the MAYO-HEGAR NEEDLE HOLDER. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982 after a review of 30 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 Conphar, Inc. devices

Submission Details

510(k) Number K821289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date June 03, 1982
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDF Guide, Needle, Surgical
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 - GDF Guide, Needle, Surgical

Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K821289.
SURGICAL INSTRUMENT GUIDE
K950007 · United States Surgical, A Division of Tyco Healthc · Mar 1995
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BIOPSY ADAPTER H4222W
K861050 · General Electric Co. · Apr 1986
OLSEN HEGAR NEEDLE HOLDERS
K821295 · Conphar, Inc. · Jun 1982
CONPHAR MAYO HEGAR NEEDLE HOLDER
K821354 · Conphar, Inc. · Jun 1982