Cleared Traditional

SURGICAL CUTTER (K955168) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955168 · Promex, Inc. · Obstetrics & Gynecology device
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Jan 1996
Decision
70d
Days
Class 2
Risk

K955168 is an FDA 510(k) clearance for the SURGICAL CUTTER. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.4400 - the FDA obstetrics and gynecology 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 Promex, Inc. devices

Submission Details

510(k) Number K955168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date January 22, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 160d · This submission: 70d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 582
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K955168.
KARL STORZ REMORGIDA FORCEPS
K962030 · KARL STORZ Endoscopy-America, Inc. · Jun 1996
ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
K960476 · Ethicon, Inc. · Apr 1996
OLYMPUS BIPOLAR FORCEPS
K955623 · Olympus America, Inc. · Feb 1996
BIOPOLAR FORCEPS LINE
K954851 · Johnson & Johnson Professionals, Inc. · Nov 1995
AESCULAP BIPOLAR CORDS
K953446 · Aesculap, Inc. · Sep 1995
TAKE-APART SCISSORS
K954122 · KARL STORZ Endoscopy-America, Inc. · Sep 1995