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510(k) K961959

MD TECH BIOPSY SET FOR BONE AND BONE MARROW by Medical Device Technologies, Inc. — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1996
Date Received
May 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Medical Device Technologies, Inc.

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  • K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (January 26, 2006)
  • K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (August 30, 2005)
  • K050873 — CANALIZER HYDROPHILIC GUIDE WIRE (May 26, 2005)
  • K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE (February 11, 2005)
  • K042464 — V-CORE FULL CORE BREAST BIOPSY INSTRUMENT (September 30, 2004)
  • K040427 — FIBREX CATHETER PATENCY DEVICE (May 3, 2004)
  • K031442 — PBN GUIDEWIRES (August 13, 2003)
  • K021606 — EN-SNARE ENDOVASCULAR SNARE AND CATHETER (May 31, 2002)
  • K011790 — MICROCRUISER PLUS INTRODUCER SET (September 5, 2001)

Other clearances for product code GAA

  • K223625 — CapnoSpot™ Pneumothorax Decompression Indicator (March 28, 2023)
  • K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (June 15, 2011)
  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K974741 — MANAN ACCURA NEEDLE (January 8, 1998)
  • K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (September 11, 1996)
  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
  • K940025 — MANAN BONE MARROW HARVEST NEEDLES (February 25, 1994)
  • K940024 — MANAN GENERAL PURPOSE INTRODUCER NEEDLE (February 25, 1994)