Home / 510(k) Clearances / K790763

510(k) K790763

MAXI-VAC TM by Med General — Product Code GCY

K790763 is an FDA 510(k) premarket notification submitted by Med General for the device "MAXI-VAC TM". The FDA issued a decision of Substantially Equivalent on April 23, 1979. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Med General has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1979
Date Received
April 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by Med General

  • K791097 — CEPTORTRODE WITH CEPTOR HESIVE (August 3, 1979)
  • K791098 — SINGLE-USE MINI-BULLDOG (June 22, 1979)
  • K790269 — CEPTOR HESIVE (February 26, 1979)
  • K782006 — MEDGENERAL SINGLE-USE BULLDOG (December 15, 1978)
  • K781239 — MYO-STIM (November 3, 1978)
  • K780632 — MAXICEPTOR (August 14, 1978)
  • K780698 — STIMULATORS, NERVE, ELECTRICAL (May 12, 1978)
  • K780117 — CARDIOMETER (February 3, 1978)
  • K771702 — VESSEL-STABILIZER (December 13, 1977)
  • K771701 — VESSEL-CLUDE (December 13, 1977)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)

FDA data resources