Cleared Traditional

K941337 - FLOWGUN ELECTROCAUTERY PROBES

K941337 is the FDA 510(k) clearance for FLOWGUN ELECTROCAUTERY PROBES by O.R. Concepts, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K941337 · O.R. Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
149d
Days
Class 2
Risk

K941337 is an FDA 510(k) clearance for the FLOWGUN ELECTROCAUTERY PROBES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by O.R. Concepts, Inc. (Burnsville, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 149 days - within the typical 510(k) review window.

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 O.R. Concepts, Inc. devices

Submission Details

510(k) Number K941337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date August 17, 1994
Days to Decision 149 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1139
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K941337.
FORCE GSU-SLPM SYSTEM
K943865 · Valleylab, Inc. · Sep 1994
FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22
K942579 · Valleylab, Inc. · Sep 1994
ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE
K943542 · Conmedcorp · Sep 1994
BIOPLAR FORCEPS
K943231 · Cook Urological, Inc. · Jul 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE
K942489 · Megadyne Medical Products, Inc. · Jul 1994
CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE
K942892 · Conmedcorp · Jul 1994