Cleared Traditional

K882036 - WILLIAMS ACS MARKER NEEDLE

K882036 is the FDA 510(k) clearance for WILLIAMS ACS MARKER NEEDLE by Buckman Co., Inc.. It is a Class 1 General & Plastic Surgery device (product code GDF) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K882036 · Buckman Co., Inc. · General & Plastic Surgery device
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Jul 1988
Decision
72d
Days
Class 1
Risk

K882036 is an FDA 510(k) clearance for the WILLIAMS ACS MARKER NEEDLE. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on July 27, 1988 after a review of 72 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K882036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1988
Decision Date July 27, 1988
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 14
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