Cleared Traditional

K843100 - INSTRUMENTS FOR MICRO ANASTOMOSIS

K843100 is an FDA 510(k) clearance for INSTRUMENTS FOR MICRO ANASTOMOSIS, manufactured by Downs Surgical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K843100 · Downs Surgical , Ltd. · General & Plastic Surgery device
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Sep 1984
Decision
51d
Days
Class 1
Risk

K843100 is an FDA 510(k) clearance for the INSTRUMENTS FOR MICRO ANASTOMOSIS. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 51 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K843100

510(k) Number K843100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1984
Decision Date September 27, 1984
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
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 39
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K843100.
21-450 GELPI RETRACTOR
K851776 · Artiberia · Jun 1985
VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42
K851108 · The Huxley Instrument Corp. · Apr 1985
FINOCCHIETO RIB RETRACTOR 1711-72 PCS. SS 303, 420
K851115 · The Huxley Instrument Corp. · Apr 1985
SURGICAL RETRACTORS-VARIOUS
K841009 · Premier Dental Products Co. · May 1984
ADHESIVE TRACTION TAPE
K834142 · Devon Industries, Inc. · Apr 1984
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984