Cleared Traditional

K080093 - PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK

K080093 is an FDA 510(k) clearance for PKS PLASMA MORCELLATOR, manufactured by Gyrus Acmi, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code GEI cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K080093 · Gyrus Acmi, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
109d
Days
Class 2
Risk

K080093 is an FDA 510(k) clearance for the PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080093

510(k) Number K080093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2008
Decision Date May 02, 2008
Days to Decision 109 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 161d · This submission: 109d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2312
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K080093.
BEAMER ARGON SNARE PROBE
K081580 · Conmed Corporation · Jun 2008
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
K080187 · Olsen Medical · May 2008
OLYMPUS ESG-100, MODEL WB991046
K073207 · Celon AG Medical Instruments · May 2008
BOVIE IDS-400 ELECTROSURGICAL GENERATOR
K072041 · Bovie Medical · Apr 2008
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
K080557 · Barrx Medical, Incorporated · Apr 2008
ERBE VIO ESU, MODEL VIO 200 S
K080715 · Erbe USA, Inc. · Apr 2008
K080093 · PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
Download PDF FDA Summary Gyrus Acmi, Inc.