Cleared Traditional

K083754 - MINI LAP ELECTROCAUTERY INSTRUMENTS

K083754 is an FDA 510(k) clearance for MINI LAP ELECTROCAUTERY INSTRUMENTS, manufactured by Mini Lap Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K083754 · Mini Lap Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
338d
Days
Class 2
Risk

K083754 is an FDA 510(k) clearance for the MINI LAP ELECTROCAUTERY INSTRUMENTS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Mini Lap Technologies, Inc. (Shelton, US). The FDA issued a Cleared decision on November 20, 2009 after a review of 338 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 Mini Lap Technologies, Inc. devices

FDA 510(k) Submission Details - K083754

510(k) Number K083754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2008
Decision Date November 20, 2009
Days to Decision 338 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
223d slower than avg
Panel avg: 115d · This submission: 338d
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 K083754.
MATRIX RF APPLICATOR
K090025 · Syneron Medical, Ltd. · Jan 2010
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
K093165 · Arthrocare Corp. · Dec 2009
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
K091824 · Ethicon Endo-Surgery, Inc. · Nov 2009
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290
K092009 · Boston Scientific Corporation · Nov 2009
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
K091290 · Ethicon Endo-Surgery, Inc. · Oct 2009
SPINEWAND SURGICAL DEVICE
K091228 · Arthrocare Corp. · Sep 2009