Cleared Traditional

K001161 - ULTRAPEN REUSABLE PENCIL

K001161 is an FDA 510(k) clearance for ULTRAPEN REUSABLE PENCIL, manufactured by Conmedcorp. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K001161 · Conmedcorp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
58d
Days
Class 2
Risk

K001161 is an FDA 510(k) clearance for the ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELE.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmedcorp (Centennial, US). The FDA issued a Cleared decision on June 7, 2000 after a review of 58 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 Conmedcorp devices

FDA 510(k) Submission Details - K001161

510(k) Number K001161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date June 07, 2000
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 1271
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K001161.
ARTHROCARE FLOW CONTROL UNIT
K001904 · Arthrocare Corp. · Jul 2000
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K001382 · Aaron Medical Industries · Jun 2000
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
K001159 · Conmedcorp · Jun 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
K001302 · Arthrocare Corp. · May 2000
SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · Aesculap, Inc. · May 2000
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
K000778 · Arthrocare Corp. · May 2000