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510(k) K914552

CMI VACUUM PUMP by Columbia Medical & Surgical, Inc. — Product Code HDA

K914552 is an FDA 510(k) premarket notification submitted by Columbia Medical & Surgical, Inc. for the device "CMI VACUUM PUMP". The FDA issued a decision of Substantially Equivalent on September 7, 1993. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400. Columbia Medical & Surgical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1993
Date Received
October 11, 1991
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 by Columbia Medical & Surgical, Inc.

  • K942725 — CMI VELVET TOUCH VACUUM EXTRACTOR (May 5, 1995)
  • K932128 — CMI E-Z FLO BULB P.N. 701 (April 7, 1994)
  • K915763 — MODIFIED DISPOSABLE FETAL VACUUM (March 18, 1992)

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)
  • 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