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510(k) K170726

Biopsy Forceps by Fehling Instruments GmbH & Co. KG — Product Code DWZ

K170726 is an FDA 510(k) premarket notification submitted by Fehling Instruments GmbH & Co. KG for the device "Biopsy Forceps". The FDA issued a decision of Substantially Equivalent on June 2, 2017. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Fehling Instruments GmbH & Co. KG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2017
Date Received
March 9, 2017
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 Fehling Instruments GmbH & Co. KG

  • K153243 — Fehling-Punches (August 4, 2016)

Other clearances for product code DWZ

  • K252722 — Biopsy Forceps (September 30, 2025)
  • 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)
  • K932788 — CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE (September 1, 1993)

FDA data resources