Cleared Traditional

K831648 - ANCHOR BRAND SURGICAL NEEDLES

K831648 is an FDA 510(k) clearance for ANCHOR BRAND SURGICAL NEEDLES, manufactured by Anchor Products Co.. The device is a Class 1 General & Plastic Surgery device with product code GAB cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K831648 · Anchor Products Co. · General & Plastic Surgery device
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Aug 1983
Decision
85d
Days
Class 1
Risk

K831648 is an FDA 510(k) clearance for the ANCHOR BRAND SURGICAL NEEDLES. Classified as Needle, Suturing, Disposable (product code GAB), Class I - General Controls.

Submitted by Anchor Products Co. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 85 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 Anchor Products Co. devices

FDA 510(k) Submission Details - K831648

510(k) Number K831648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date August 16, 1983
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

GAB Device Classification - Class 1, General Controls

Product Code GAB Needle, Suturing, 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 - GAB Needle, Suturing, Disposable

Devices cleared under the same product code (GAB) and FDA review panel - the closest regulatory comparables to K831648.
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
K980988 · Axya Medical, Inc. · May 1998
CONTRAST BACKGROUND MATERIAL
K895681 · Applied Medical Technologies · Oct 1989
RADIATION STERILIZATION FOR NEEDLE CNTR
K812444 · Devon Industries, Inc. · Dec 1981
SCANLAN STERNUM NEEDLE-SUTURE
K801976 · Scanlan Intl., Inc. · Sep 1980