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510(k) K072051

NOVATOME, MODEL: SU101-50 by Scholten Surgical Instruments, Inc. — Product Code DWZ

K072051 is an FDA 510(k) premarket notification submitted by Scholten Surgical Instruments, Inc. for the device "NOVATOME, MODEL: SU101-50". The FDA issued a decision of Substantially Equivalent on October 3, 2007. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Scholten Surgical Instruments, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2007
Date Received
July 26, 2007
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 Scholten Surgical Instruments, Inc.

  • K900405 — SCHOLTEN FRAME (March 1, 1990)
  • K852331 — SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC (August 1, 1986)
  • K852119 — TEMPORARY PACEMAKER GROUND WIRE (September 15, 1985)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)
  • K852120 — FORCEPS, BIOPSY(NON RIGID) (July 2, 1985)
  • K852330 — RETRACTOR, SURGICAL (June 27, 1985)
  • K852329 — STAND, OPERATING ROOM (June 14, 1985)

Other clearances for product code DWZ

  • K252722 — Biopsy Forceps (September 30, 2025)
  • K170726 — Biopsy Forceps (June 2, 2017)
  • K010473 — SPARROWHAWK DISPOSABLE (June 6, 2001)
  • K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS (February 28, 2000)
  • K991486 — ULTRA-CBX (November 5, 1999)
  • K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER (December 16, 1997)
  • K973818 — T-REX BIOPSY FORCEPS (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