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510(k) K970083

DYNABITE HOT GI BIOPSY FORCEPS by Portlyn Corp. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1997
Date Received
January 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Portlyn Corp.

  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K944245 — DYNABITE LAPAROSCOPIC FORCEPS (November 15, 1994)
  • K934506 — DYNABITE HYSTEROSCOPIC FORCEPS (March 22, 1994)
  • K901300 — BIOPSY FORCEPS (June 29, 1990)
  • K896147 — BIOPSY FORCEP (NON-ELECTRIC) (April 16, 1990)
  • K896146 — BIOPSY FORCEPS, (NON-RIGID) (March 9, 1990)

Other clearances for product code KGE

  • K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (March 6, 2026)
  • K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
  • K242857 — ClearHemograsper (May 21, 2025)
  • K231721 — Disposable Hot Biopsy Forceps (December 14, 2023)
  • K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (February 4, 2022)
  • K210406 — Bipolar Coagulation Foreceps (October 5, 2021)
  • K202438 — Ensure Single-Use Coagulation Forceps (March 15, 2021)
  • K183428 — Avulsion Forceps (April 16, 2019)
  • K180018 — Disposable Hot Biopsy Forceps (July 5, 2018)
  • K180134 — Ensizor Monopolar Endoscopic Scissors (June 29, 2018)