Cleared Traditional

OPTICAL SEPARATOR (K032889) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032889 · Applied Medical Resources · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
15d
Days
Class 2
Risk

K032889 is an FDA 510(k) clearance for the OPTICAL SEPARATOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Applied Medical Resources (Rancho Santa, US). The FDA issued a Cleared decision on October 2, 2003 after a review of 15 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 Applied Medical Resources devices

Submission Details

510(k) Number K032889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date October 02, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 463
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K032889.
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
K041827 · Boston Scientific Corp · Aug 2004
DAVOL DELIVERY SYSTEM
K041641 · C.R. Bard, Inc. · Jul 2004
ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR
K032676 · Ethicon Endo-Surgery, Inc. · Oct 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · Smith & Nephew, Inc. · Sep 2003
ENDOSCOPIC APPLICATOR
K031882 · Baxter Healthcare Corp · Sep 2003
CARDIOVATIONS PORTABLE VIDEO SYSTEM
K032339 · Ethicon, Inc. · Aug 2003