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510(k) K901300

BIOPSY FORCEPS by Portlyn Corp. — Product Code DWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1990
Date Received
March 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biopsy, Endomyocardial
Device Class
Class II
Regulation Number
870.4075
Review Panel
CV
Submission Type

Other clearances by Portlyn Corp.

  • K970083 — DYNABITE HOT GI BIOPSY FORCEPS (June 17, 1997)
  • 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)
  • K896147 — BIOPSY FORCEP (NON-ELECTRIC) (April 16, 1990)
  • K896146 — BIOPSY FORCEPS, (NON-RIGID) (March 9, 1990)

Other clearances for product code DWZ

  • K252722 — Biopsy Forceps (September 30, 2025)
  • K170726 — Biopsy Forceps (June 2, 2017)
  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K010473 — SPARROWHAWK DISPOSABLE (June 6, 2001)
  • K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS (February 28, 2000)
  • K991486 — ULTRA-CBX (November 5, 1999)
  • K973818 — T-REX BIOPSY FORCEPS (December 16, 1997)
  • K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER (December 16, 1997)
  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K933235 — CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF (January 6, 1994)