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510(k) K980238

GYNEX EXTENDED REACH NEEDLE by Gynex Corp. — Product Code HEE

K980238 is an FDA 510(k) premarket notification submitted by Gynex Corp. for the device "GYNEX EXTENDED REACH NEEDLE". The FDA issued a decision of Substantially Equivalent on August 21, 1998. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. Gynex Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1998
Date Received
January 23, 1998
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 Gynex Corp.

  • K061306 — CO-1000 COLPOSCOPE, MULTIPLE (August 7, 2006)
  • K982739 — GYNEX ELECTRODES (March 12, 1999)
  • K980237 — GYNEX ENDOSPECULUM (April 8, 1998)
  • K980247 — GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM (March 17, 1998)

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)
  • K973671 — ENDOCERVICAL BLOCK NEEDLE (November 26, 1997)
  • K954718 — ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE (February 29, 1996)
  • K910253 — LEEP REDIKIT (April 18, 1991)
  • K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (March 4, 1991)

FDA data resources