Cleared Traditional

FLEXI-TY (K832765) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
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Jan 1984
Decision
164d
Days
Class 1
Risk

K832765 is an FDA 510(k) clearance for the FLEXI-TY. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K832765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date January 27, 1984
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
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 - GAD Retractor

All 9
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K832765.
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · United States Surgical, A Division of Tyco Healthc · May 1992
STERI-TRACTOR WOUND RETRACTOR
K870543 · 3M Company · Feb 1987
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983
ETHICON RETRACTION TAPE
K801699 · Ethicon, Inc. · Sep 1980
ULTRASOUND IMAGING SYSTEM
K780993 · Boehringer Mannheim Corp. · Aug 1978