Home / 510(k) Clearances / K981389

510(k) K981389

DISPOSABLE RE-NEW FORCEPS by Microline Pentax, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1998
Date Received
April 16, 1998
Clearance Type
Traditional
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 Microline Pentax, Inc.

  • K013695 — MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIP (January 8, 2002)
  • K982984 — ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS (October 21, 1998)
  • K981188 — ELECTROSURGICAL CAUTERY PROBES (May 20, 1998)
  • K980758 — 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS (March 27, 1998)
  • K974066 — RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS (January 22, 1998)
  • K970826 — SELECTA-TIP LAPAROSCOPIC SCISSORS (March 28, 1997)
  • K962119 — RE-NEW LAPAROSCOPIC INSTRUMENTS (August 9, 1996)
  • K932648 — QUICK SWITCH LAPAROSCOPIC INSTRUMENTS (October 12, 1993)
  • K897093 — INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (April 4, 1990)
  • K881049 — BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (September 12, 1988)

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)