Cleared Traditional

K813338 - BIOPSY NEEDLES & TRAYS

K813338 is an FDA 510(k) clearance for BIOPSY NEEDLES & TRAYS, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 General & Plastic Surgery device with product code FSH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K813338 · American Pharmaseal Div. Ahsc · General & Plastic Surgery device
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Jan 1982
Decision
65d
Days
Class 1
Risk

K813338 is an FDA 510(k) clearance for the BIOPSY NEEDLES & TRAYS. Classified as Tray, Surgical, Needle (product code FSH), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 65 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K813338

510(k) Number K813338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1981
Decision Date January 28, 1982
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

FSH Device Classification - Class 1, General Controls

Product Code FSH Tray, Surgical, Needle
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 - FSH Tray, Surgical, Needle

Devices cleared under the same product code (FSH) and FDA review panel - the closest regulatory comparables to K813338.
S 4 INSTRUMENT STAND
K884876 · Carl Zeiss, Inc. · Dec 1988
S 21 INSTRUMENT STAND
K883578 · Carl Zeiss, Inc. · Sep 1988
SKINNY CHIBA NEEDLE & TRAY
K813337 · American Pharmaseal Div. Ahsc · Jan 1982
PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
K813335 · American Pharmaseal Div. Ahsc · Jan 1982
FSH RIA KIT (125I)
K772188 · Diagnostic Products Corp. · Dec 1977