Home / 510(k) Clearances / K974312

510(k) K974312

REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR by Telemed Systems, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1998
Date Received
November 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Telemed Systems, Inc.

  • K020379 — PPD BALLOON DILATATION CATHETER (May 6, 2002)
  • K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (March 1, 2002)
  • K010412 — FLEXIBLE ENDOSCOPIC SCISSORS (April 2, 2001)
  • K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM (December 22, 1999)
  • K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 (December 22, 1999)
  • K974300 — TELEMED SYSTEMS RETRIEVAL BASKET (December 19, 1997)
  • K901435 — GASTROINTESTINAL CYTOLOGY BRUSH (July 16, 1990)
  • K901427 — BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON (June 22, 1990)
  • K901433 — SURE-FLEX ANASTOMOTIC BALLOON DILATOR (June 21, 1990)
  • K901425 — PYLORIC BALLOON DILATOR (June 21, 1990)

Other clearances for product code KNW

  • K260365 — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma (March 4, 2026)
  • K252795 — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De (February 23, 2026)
  • K252681 — EnCor EnCompass™ Breast Biopsy and Tissue Removal System (December 12, 2025)
  • K252183 — Resitu Slider 09 (RESL09) (September 24, 2025)
  • K243407 — Forcyte Autograft Harvest Kit (July 29, 2025)
  • K244018 — Disposable Biopsy Needle (July 22, 2025)
  • K243296 — Disposable Biopsy Needle (July 11, 2025)
  • K250032 — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (July 10, 2025)
  • K243886 — ExpressCore Biopsy Device (April 29, 2025)
  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)