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510(k) K013747

TEKNO-MEDICAL OBSTETRICAL FORCEPS by Tekno Medical Optik-Chirurgie GmbH & Co. — Product Code HDA

K013747 is an FDA 510(k) premarket notification submitted by Tekno Medical Optik-Chirurgie GmbH & Co. for the device "TEKNO-MEDICAL OBSTETRICAL FORCEPS". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400. Tekno Medical Optik-Chirurgie GmbH & Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
November 13, 2001
Clearance Type
Abbreviated
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 by Tekno Medical Optik-Chirurgie GmbH & Co.

  • K003717 — INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCO (March 1, 2001)

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)
  • 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)
  • K771106 — FORCEPS, OB, NON-COMPRESSIVE (July 1, 1977)

FDA data resources