Cleared Traditional

K955792 - WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA0

K955792 is an FDA 510(k) clearance for WILO SERIES SECUR, manufactured by Wilo Medizintechnik Lothar Wilberg GmbH. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K955792 · Wilo Medizintechnik Lothar Wilberg GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
217d
Days
Class 2
Risk

K955792 is an FDA 510(k) clearance for the WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, .... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Wilo Medizintechnik Lothar Wilberg GmbH (Washington, US). The FDA issued a Cleared decision on July 26, 1996 after a review of 217 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 Wilo Medizintechnik Lothar Wilberg GmbH devices

FDA 510(k) Submission Details - K955792

510(k) Number K955792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date July 26, 1996
Days to Decision 217 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 115d · This submission: 217d
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 1658
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K955792.
VALLEYLAB COATED ELECTRODES
K962044 · Valleylab, Inc. · Aug 1996
BIPOLAR PENCIL COAGULATOR
K962678 · Kirwan Surgical Products, Inc. · Aug 1996
RE-NEW LAPAROSCOPIC INSTRUMENTS
K962119 · Microline Pentax, Inc. · Aug 1996
ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
K961264 · Ethicon Endo-Surgery, Inc. · Jul 1996
BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
K961505 · Conmedcorp · Jul 1996
SYSTEM 6500 ABC ELECTROSURGICAL UNIT
K955834 · Aspen Laboratories, Inc. · Jul 1996