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510(k) K871087

S.C.M.T. PERFORATOR by Salt Creek Medical Technologies — Product Code HGE

K871087 is an FDA 510(k) premarket notification submitted by Salt Creek Medical Technologies for the device "S.C.M.T. PERFORATOR". The FDA issued a decision of Substantially Equivalent on March 23, 1987. The device falls under product code HGE (Amniotome), a Class I device regulated under 21 CFR 884.4530. Salt Creek Medical Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1987
Date Received
March 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amniotome
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Salt Creek Medical Technologies

  • K864683 — NEONATAL FEEDING KIT (April 17, 1987)
  • K871042 — URINE METER, 250CC (March 25, 1987)
  • K871075 — SCMT UMBILICAL CLAMP (March 23, 1987)
  • K864296 — S.C.T. MULTI PORT, INJECTION SITE (March 2, 1987)
  • K864682 — SALT CREEK P.I. TRAY (January 6, 1987)
  • K864692 — EXTENSION SETS (December 18, 1986)
  • K864693 — I.V. START KITS (December 16, 1986)

Other clearances for product code HGE

  • K951148 — OBSTI-HOOK (June 9, 1995)
  • K926425 — AMNIPERF(TM) (March 7, 1994)
  • K910518 — GLOVE-N-GEL AMNIOTOMY KIT (May 9, 1991)
  • K850758 — AMNIGLOVE & AMNICOT (April 15, 1985)
  • K834177 — H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 (December 27, 1983)

FDA data resources