Cleared Traditional

K852330 - RETRACTOR, SURGICAL

K852330 is an FDA 510(k) clearance for RETRACTOR, manufactured by Scholten Surgical Instruments, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K852330 · Scholten Surgical Instruments, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
27d
Days
Class 1
Risk

K852330 is an FDA 510(k) clearance for the RETRACTOR, SURGICAL. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Scholten Surgical Instruments, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 27, 1985 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 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 Scholten Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K852330

510(k) Number K852330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date June 27, 1985
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.

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 57
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K852330.
RAYLOR RETRACTORS
K853796 · Cedar Surgical, Inc. · Oct 1985
3M FUKUDA TYPE RING RETRACTOR
K852567 · 3M Company · Jul 1985
WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS
K852530 · The Huxley Instrument Corp. · Jun 1985
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