Cleared Traditional

K032965 - LAPAROSCOPIC INSTRUMENT

K032965 is an FDA 510(k) clearance for LAPAROSCOPIC INSTRUMENT, manufactured by Modern Medical Equipment Mfg., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K032965 · Modern Medical Equipment Mfg., Ltd. · General & Plastic Surgery device
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May 2004
Decision
233d
Days
Class 2
Risk

K032965 is an FDA 510(k) clearance for the LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Modern Medical Equipment Mfg., Ltd. (Kwai Chung N.T., HK). The FDA issued a Cleared decision on May 13, 2004 after a review of 233 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Modern Medical Equipment Mfg., Ltd. devices

FDA 510(k) Submission Details - K032965

510(k) Number K032965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2003
Decision Date May 13, 2004
Days to Decision 233 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 115d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1195
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K032965.
SENORX INTRODUCER
K042098 · Senorx, Inc. · Aug 2004
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
K041328 · Smith & Nephew, Inc. · Jul 2004
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
K040699 · Megadyne Medical Products, Inc. · Jun 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · Boston Scientific Corp · Apr 2004
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06
K040338 · Arthrocare Corp. · Mar 2004
COLORADO MICRODISSECTION NEEDLE
K033232 · Stryker Corp. · Feb 2004