Cleared Traditional

K932466 - MEDCHEM SURGICAL DELIVERY SYSTEM

K932466 is the FDA 510(k) clearance for MEDCHEM SURGICAL DELIVERY SYSTEM by Medco Products, Co., Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K932466 · Medco Products, Co., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
80d
Days
Class 2
Risk

K932466 is an FDA 510(k) clearance for the MEDCHEM SURGICAL DELIVERY SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Medco Products, Co., Inc. (Woburn, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Medco Products, Co., Inc. devices

Submission Details

510(k) Number K932466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1993
Decision Date August 09, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 694
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K932466.
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932976 · Cabot Medical Corp. · Sep 1993
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
K932977 · Cabot Medical Corp. · Sep 1993
SURGICAL TROCAR AND TROCAR SLEEVE
K932229 · Origin Medsystems, Inc. · Aug 1993
LAPAROSCOPIC BALLOON RETRACTOR
K931649 · Cabot Medical Corp. · Aug 1993
ENDOSWAB
K931898 · Medline Industries, Inc. · Jul 1993
MICRO ENDOSCOPIC ELECTRODE (ME2)
K931281 · Codman & Shurtleff, Inc. · Jul 1993