Cleared Traditional

K832765 - FLEXI-TY

K832765 is an FDA 510(k) clearance for FLEXI-TY, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K832765

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.

GAD Device Classification - Class 1, General Controls

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 60
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K832765.
INSTRUMENTS FOR MICRO ANASTOMOSIS
K843100 · Downs Surgical , Ltd. · Sep 1984
SURGICAL RETRACTORS-VARIOUS
K841009 · Premier Dental Products Co. · May 1984
ADHESIVE TRACTION TAPE
K834142 · Devon Industries, Inc. · Apr 1984
H.R. JAKOBI SURG. INSTRUMENTS #11 16/46
K834181 · Imm Enterprises , Ltd. · Jan 1984
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37
K834196 · Imm Enterprises , Ltd. · Jan 1984
ZIMMER SKIN PROTECTOR
K830287 · Zimmer, Inc. · Mar 1983