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510(k) K910071

PORTA GAS COMPRESSED GAS CYLINDER CART by Sen Tech Medical Corp. — Product Code GET

K910071 is an FDA 510(k) premarket notification submitted by Sen Tech Medical Corp. for the device "PORTA GAS COMPRESSED GAS CYLINDER CART". The FDA issued a decision of Substantially Equivalent on March 22, 1991. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Sen Tech Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1991
Date Received
January 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Sen Tech Medical Corp.

  • K855091 — CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS (March 14, 1986)
  • K854260 — CHEMPRO 1000 (November 19, 1985)
  • K851100 — CHEM PRO 1000 CHEMISTRY ANALYSIS (July 9, 1985)
  • K841575 — SENTECH'S ULAB 1000 CLINICAL CHEM. (July 6, 1984)

Other clearances for product code GET

  • K960473 — AESCULAP POWER SYSTEM HANDPIECE (March 7, 1996)
  • K955174 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (January 22, 1996)
  • K942987 — NUCLEOTOME L KIT (October 30, 1995)
  • K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (October 18, 1995)
  • K953433 — MIDAS REX TELESCOPING SYSTEM (September 15, 1995)
  • K953432 — ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (September 14, 1995)
  • K952463 — GS & GS20 SURGICAL TOOL SYSTEM (July 17, 1995)
  • K952300 — MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (May 26, 1995)
  • K914753 — AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (June 11, 1992)
  • K904578 — MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP (October 30, 1990)

FDA data resources