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510(k) K954718

ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE by Ellman Intl., Inc. — Product Code HEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1996
Date Received
October 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Anesthesia, Paracervical
Device Class
Class II
Regulation Number
884.5100
Review Panel
OB
Submission Type

Other clearances by Ellman Intl., Inc.

  • K013255 — SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF (November 7, 2001)
  • K003126 — BIPOLAR TRIGGER-FLEX PROBE (April 11, 2001)
  • K001986 — SURGITRON IEC II (September 27, 2000)
  • K001407 — SURGITRON IEC II (July 24, 2000)
  • K001253 — SURGITRON IEC II (May 26, 2000)
  • K992382 — SURGITRON RADIOLASE (October 14, 1999)
  • K990146 — SURGITRON (March 17, 1999)
  • K980177 — SUGITRON MODEL: IEC (July 7, 1998)
  • K980170 — SURGITRON (June 29, 1998)
  • K972072 — SURGITRON MODEL FFPF-EMC (June 19, 1997)

Other clearances for product code HEE

  • K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (October 17, 2005)
  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K000117 — AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE (April 13, 2000)
  • K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 3 (February 1, 1999)
  • K980238 — GYNEX EXTENDED REACH NEEDLE (August 21, 1998)
  • K973671 — ENDOCERVICAL BLOCK NEEDLE (November 26, 1997)
  • K910253 — LEEP REDIKIT (April 18, 1991)
  • K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (March 4, 1991)