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510(k) K021224

ENDOCERVICAL BLOCK NEEDLE by Wallach Surgical Devices, Inc. — Product Code HEE

K021224 is an FDA 510(k) premarket notification submitted by Wallach Surgical Devices, Inc. for the device "ENDOCERVICAL BLOCK NEEDLE". The FDA issued a decision of Substantially Equivalent on July 12, 2002. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. Wallach Surgical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2002
Date Received
April 17, 2002
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 Wallach Surgical Devices, Inc.

  • K020711 — WALLACH LOOP ELECTRODE (June 3, 2002)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM (September 29, 1999)
  • K991669 — PMS 750 FINGERSWITCH (August 12, 1999)
  • K983840 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (May 20, 1999)
  • K984306 — `THE INSEMINATOR' (PROPOSED) (March 1, 1999)
  • K983208 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (February 22, 1999)
  • K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM (June 11, 1997)
  • K963348 — WALLACH INTEGRATION UNIT (March 19, 1997)
  • K950630 — WALLACH DIGITAL IMAGING SYSTEM (November 22, 1995)

Other clearances for product code HEE

  • K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (October 17, 2005)
  • 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)
  • 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