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510(k) K010487

BIPOLAR PENCIL, MODEL 3901-002, 3900-002 by Medtronic PS Medical — Product Code GEI

K010487 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "BIPOLAR PENCIL, MODEL 3901-002, 3900-002". The FDA issued a decision of Substantially Equivalent on May 3, 2001. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400. Medtronic PS Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2001
Date Received
February 20, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by Medtronic PS Medical

  • K012052 — MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 (February 11, 2002)
  • K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 (May 7, 2001)
  • K010341 — MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2 (April 20, 2001)
  • K003914 — MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES (February 22, 2001)
  • K002572 — MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003 (November 16, 2000)
  • K991502 — MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 (September 12, 2000)
  • K990333 — MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3 (April 28, 1999)
  • K984053 — BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM (February 4, 1999)
  • K983799 — MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAG (January 26, 1999)
  • K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (December 16, 1998)

Other clearances for product code GEI

  • K253504 — Volnewmer™ (July 13, 2026)
  • K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 (July 1, 2026)
  • K251492 — Irrigation Tubing Bipolar Cord Set (June 29, 2026)
  • K253484 — LUTRONIC GENIUS (June 29, 2026)
  • K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (June 18, 2026)
  • K253634 — CoolSeal Generator® (CSL-200-90) (June 17, 2026)
  • K261833 — NEUROMARK System (NMK00301) (June 16, 2026)
  • K253165 — LAP-iX2N (June 9, 2026)
  • K253656 — OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (June 5, 2026)
  • K253803 — MILAN System (June 2, 2026)

FDA data resources