Cleared Traditional

K032327 - MODERN MEDICAL BIPOLAR FORCEPS

K032327 is an FDA 510(k) clearance for MODERN MEDICAL BIPOLAR FORCEPS, 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 323-day FDA review.

K032327 · Modern Medical Equipment Mfg., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
323d
Days
Class 2
Risk

K032327 is an FDA 510(k) clearance for the MODERN MEDICAL BIPOLAR FORCEPS. 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 June 15, 2004 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K032327

510(k) Number K032327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2003
Decision Date June 15, 2004
Days to Decision 323 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
208d slower than avg
Panel avg: 115d · This submission: 323d
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 K032327.
VALUPEN,PROFILE
K041868 · Conmed Corporation · Sep 2004
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