Cleared Traditional

MINISITE*BIPOLAR FORCEPS** DEVICE (K972415) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972415 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 1997
Decision
84d
Days
Class 2
Risk

K972415 is an FDA 510(k) clearance for the MINISITE*BIPOLAR FORCEPS** DEVICE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on September 19, 1997 after a review of 84 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K972415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1997
Decision Date September 19, 1997
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 591
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K972415.
BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451
K973295 · Richard Wolf Medical Instruments Corp. · Nov 1997
HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE
K973341 · Richard Wolf Medical Instruments Corp. · Nov 1997
POWERSTAR BIPOLAR SCISSORS
K973173 · Ethicon, Inc. · Oct 1997
GRASPING FORCEPS, RIGHT AND LEFT CURVED
K972519 · Richard Wolf Medical Instruments Corp. · Sep 1997
KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
K972497 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
AESCULAP JET IRRIGATION SYSTEM
K971310 · Aesculap, Inc. · Jul 1997