Cleared Traditional

TRIANGULAR BANDAGE CAT.#191 (K802006) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K802006 · Pollak (Intl.), Ltd. · General & Plastic Surgery device
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Sep 1980
Decision
27d
Days
Class 1
Risk

K802006 is an FDA 510(k) clearance for the TRIANGULAR BANDAGE CAT.#191. Classified as Sling, Arm (product code ILI), Class I - General Controls.

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 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 890.3640 - 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 Pollak (Intl.), Ltd. devices

Submission Details

510(k) Number K802006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date September 16, 1980
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.

Device Classification

Product Code ILI Sling, Arm
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3640
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 - ILI Sling, Arm

All 20
Devices cleared under the same product code (ILI) and FDA review panel - the closest regulatory comparables to K802006.
ARM SLINGS
K831549 · Fred Sammons, Inc. · Jun 1983
ARM SLINGS
K812345 · Fred Sammons, Inc. · Sep 1981
BAUER & BLACK ARM SLING W/DETACH. POUCH
K803212 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1981
BK-6157-02 C.V.A SLING, MEDIUM&LARGE
K801713 · Fred Sammons, Inc. · Aug 1980
BANDAGE, TRIANGULAR NO. 8068
K760250 · Johnson & Johnson Professionals, Inc. · Jul 1976