Cleared Traditional

K033095 - SMOKE EVACUATION ATTACHEMENT

K033095 is an FDA 510(k) clearance for SMOKE EVACUATION ATTACHEMENT, 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 415-day FDA review.

K033095 · Modern Medical Equipment Mfg., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
415d
Days
Class 2
Risk

K033095 is an FDA 510(k) clearance for the SMOKE EVACUATION ATTACHEMENT. 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 November 17, 2004 after a review of 415 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Modern Medical Equipment Mfg., Ltd. devices

FDA 510(k) Submission Details - K033095

510(k) Number K033095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 17, 2004
Days to Decision 415 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
300d slower than avg
Panel avg: 115d · This submission: 415d
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 K033095.
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
K050102 · Megadyne Medical Products, Inc. · Feb 2005
SERFAS ENERGY SYSTEM
K041810 · Stryker Endoscopy · Dec 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
K043291 · Medtronic Vascular · Dec 2004
VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS
K042604 · Valley Forge Scientific Corp. · Oct 2004
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
K033421 · Erbe USA, Inc. · Oct 2004
VALUPEN,PROFILE
K041868 · Conmed Corporation · Sep 2004