Cleared Traditional

K833541 - SURGICAL INSTRUMENT

K833541 is an FDA 510(k) clearance for SURGICAL INSTRUMENT, manufactured by Hirata Sangyo Co. USA, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K833541 · Hirata Sangyo Co. USA, Inc. · General & Plastic Surgery device
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Nov 1983
Decision
62d
Days
Class 1
Risk

K833541 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Hirata Sangyo Co. USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 62 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 Hirata Sangyo Co. USA, Inc. devices

FDA 510(k) Submission Details - K833541

510(k) Number K833541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1983
Decision Date November 28, 1983
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 61
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K833541.
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 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
PILLING IDENTI-LOOPS
K820377 · Narco Scientific · Mar 1982
SELF RETAINING RETRACTOR FOR HAND SURG
K820290 · The Anspach Effort, Inc. · Mar 1982