Cleared Traditional

K813448 - POTTS-COURNAND STYLE NEEDLE

K813448 is an FDA 510(k) clearance for POTTS-COURNAND STYLE NEEDLE, manufactured by Ocean Medical Products, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K813448 · Ocean Medical Products, Ltd. · General & Plastic Surgery device
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Jan 1982
Decision
27d
Days
Class 1
Risk

K813448 is an FDA 510(k) clearance for the POTTS-COURNAND STYLE NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Ocean Medical Products, Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1982 after a review of 27 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 Ocean Medical Products, Ltd. devices

FDA 510(k) Submission Details - K813448

510(k) Number K813448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1981
Decision Date January 07, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
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 - GAA Needle, Aspiration And Injection, Disposable

All 75
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K813448.
INJECTION ASPIRATING NEEDLES
K821697 · American Endoscopy, Inc. · Jun 1982
VARIOUS STERILE BIOPSY ASPIRATION NEED
K821017 · Medsurg Industries, Inc. · Jun 1982
HYPODERMIC NEEDLES & SYRINGES
K821348 · Medi-Tech, Inc. · Jun 1982
CUATICO MYELOGRAPHY NEEDLES
K813367 · Dlp, Inc. · Jan 1982
DISPOSABLE CHIBA-TYPE NEEDLE
K813368 · Dlp, Inc. · Jan 1982
PHERESIS NEEDLE ASSEMBLY
K810076 · Haemonetics Corp. · Mar 1981