Home / 510(k) Clearances / K061975

510(k) K061975

PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK by Acmi Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2006
Date Received
July 13, 2006
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 Acmi Corporation

  • K060752 — ACMI DUR-HL LASER SYSTEMS (May 25, 2006)
  • K060269 — ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM (March 31, 2006)
  • K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 61224 (September 2, 2005)
  • K052044 — ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL (August 16, 2005)
  • K043581 — DUAL LUMEN CATHETER (March 3, 2005)
  • K042069 — INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM (November 1, 2004)
  • K042225 — ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (September 10, 2004)
  • K031758 — ACMI M4 TELESCOPES (September 2, 2003)
  • K030960 — ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE (July 16, 2003)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)

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)