Home / 510(k) Clearances / K993647

510(k) K993647

UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F by Unimed Surgical Products, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1999
Date Received
October 29, 1999
Clearance Type
Special
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 Unimed Surgical Products, Inc.

  • K132224 — UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES (October 8, 2013)
  • K970066 — UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE (February 18, 1997)
  • K963338 — UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH (October 21, 1996)
  • K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE (September 3, 1996)
  • K944450 — SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE (July 25, 1995)
  • K944265 — NEEDLE ELCTRODE (May 5, 1995)
  • K946246 — SURGI-LINK BIPOLAR MICRO FORCEPS (March 7, 1995)
  • K945030 — SURGI-LINK LAPAROSCOPIC ELECTRODES (November 3, 1994)
  • K944898 — SURGI-LINK BIPOLAR ELECTRODES (November 1, 1994)
  • K944617 — SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL (September 29, 1994)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)