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510(k) K982984

ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS by Microline Pentax, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1998
Date Received
August 26, 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)
  • K981389 — DISPOSABLE RE-NEW FORCEPS (May 29, 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)

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