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510(k) K771106

FORCEPS, OB, NON-COMPRESSIVE by Zeppelin Medizinlechnik GmbH — Product Code HDA

K771106 is an FDA 510(k) premarket notification submitted by Zeppelin Medizinlechnik GmbH for the device "FORCEPS, OB, NON-COMPRESSIVE". The FDA issued a decision of Substantially Equivalent on July 1, 1977. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1977
Date Received
June 20, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Obstetrical
Device Class
Class II
Regulation Number
884.4400
Review Panel
OB
Submission Type

Other clearances for product code HDA

  • K100517 — INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (April 29, 2010)
  • K092827 — DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX (January 8, 2010)
  • K013747 — TEKNO-MEDICAL OBSTETRICAL FORCEPS (February 11, 2002)
  • K951529 — V. MUELLER OBSTETRICAL (OB) FORCEPS (August 4, 1995)
  • K914552 — CMI VACUUM PUMP (September 7, 1993)
  • K905583 — ILC FORCEPS PADS (April 12, 1991)
  • K903205 — AUTO SUTURE(R) ENDOSCOPIC CLAMP (October 11, 1990)
  • K890385 — MIDWIFERY/OBSTETRICAL FORCEPS (March 1, 1989)
  • K851883 — SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 (May 9, 1985)

FDA data resources