Cleared Traditional

K170377 - TipControl RF INSTRUMENT BIPO Ø 2.5MM W...

K170377 is an FDA 510(k) clearance for TipControl RF INSTRUMENT BIPO Ø 2.5MM W..., manufactured by Richard Wolf Medical Instruments Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K170377 · Richard Wolf Medical Instruments Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
57d
Days
Class 2
Risk

K170377 is an FDA 510(k) clearance for the TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on April 5, 2017 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard Wolf Medical Instruments Corporation devices

FDA 510(k) Submission Details - K170377

510(k) Number K170377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2017
Decision Date April 05, 2017
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
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 1259
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K170377.
PK AIM
K170908 · Gyrus Acmi, Inc. · May 2017
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
K170869 · Covidien · Apr 2017
SlimShape System
K163415 · Syneron Medical, Ltd. · Apr 2017
Valleylab FT10 Electrosurgical Platform
K170170 · Covidien, LLC · Feb 2017
ENSEAL X1 Large Jaw Tissue Sealer
K163548 · Ethicon Endo-Surgery, LLC · Feb 2017
OsteoCool V-3 RF Ablation System
K161949 · Baylis Medical Company, Inc. · Jan 2017