Cleared Traditional

K863090 - PERCU GUIDE I (LOOP TYPE)

K863090 is the FDA 510(k) clearance for PERCU GUIDE I (LOOP TYPE) by E-Z-Em, Inc.. It is a Class 1 General & Plastic Surgery device (product code GDF) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K863090 · E-Z-Em, Inc. · General & Plastic Surgery device
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Aug 1986
Decision
16d
Days
Class 1
Risk

K863090 is an FDA 510(k) clearance for the PERCU GUIDE I (LOOP TYPE). Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on August 29, 1986 after a review of 16 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K863090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date August 29, 1986
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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

All 13
Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K863090.
SURGICAL NEEDLE HOLDERS
K890229 · Kinetic Medical Products · Jan 1989
WILLIAMS ACS MARKER NEEDLE
K882036 · Buckman Co., Inc. · Jul 1988
BIOPSY ADAPTER #H4221BG
K864551 · General Electric Co. · Dec 1986
BIOPSY ADAPTER H4222W
K861050 · General Electric Co. · Apr 1986
MAYO-HEGAR NEEDLE HOLDER
K821289 · Conphar, Inc. · Jun 1982
OLSEN HEGAR NEEDLE HOLDERS
K821295 · Conphar, Inc. · Jun 1982