Cleared Traditional

K971540 - AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD

K971540 is an FDA 510(k) clearance for AMERICAN BIOSURGICAL ELECTROSURGICAL MO..., manufactured by American Biosurgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K971540 · American Biosurgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
108d
Days
Class 2
Risk

K971540 is an FDA 510(k) clearance for the AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by American Biosurgical, Inc. (Norcross, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 108 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 American Biosurgical, Inc. devices

FDA 510(k) Submission Details - K971540

510(k) Number K971540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date August 14, 1997
Days to Decision 108 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
7d faster than avg
Panel avg: 115d · This submission: 108d
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 1470
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K971540.
THERMOGARD & THERMOGARD PLUS ABC
K972628 · Conmedcorp · Aug 1997
MODEL 50 BIPOLAR COAGULATOR
K972350 · Boston Surgical Products, Inc. · Aug 1997
ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD
K971677 · Transamerican Technologies Intl. · Aug 1997
ARTHROCARE ELECTROSURGERY SYSTEM
K971532 · Arthrocare Corp. · Jul 1997
CAUTERIZATION SMOKE EVACUATOR
K971758 · Applied Medical Technologies · Jul 1997
AESCULAP JET IRRIGATION SYSTEM
K971310 · Aesculap, Inc. · Jul 1997