Cleared Traditional

K911904 - MODELS UES-10 & PSD-10

K911904 is the FDA 510(k) clearance for MODELS UES-10 & PSD-10 by Olympus Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K911904 · Olympus Corp. · General & Plastic Surgery device
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Jul 1991
Decision
88d
Days
Class 2
Risk

K911904 is an FDA 510(k) clearance for the MODELS UES-10 & PSD-10. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 88 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 Olympus Corp. devices

Submission Details

510(k) Number K911904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date July 26, 1991
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 1182
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K911904.
E-Z CLEAN ELECTRODE
K913473 · Megadyne Medical Products, Inc. · Sep 1991
ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS
K912337 · Megadyne Medical Products, Inc. · Aug 1991
E-Z CLEAN LAPAROSCOPIC ELECTRODE
K913281 · Megadyne Medical Products, Inc. · Aug 1991
LAPAROSCOPIC ELECTRODE WITH LAVAGE AND SUCTION
K911476 · United States Endoscopy Group, Inc. · Jul 1991
LAPAROSCOPIC ELECTRODE
K911491 · United States Endoscopy Group, Inc. · Jul 1991
COOK TISSUE MORCELLATOR
K910939 · Cook Urological, Inc. · Jun 1991