Home / 510(k) Clearances / K093479

510(k) K093479

DISPOSABLE SUCTION AND IRRIGATION SYSTEM by Modern Medical Equipment Mfg., Ltd. — Product Code FHF

K093479 is an FDA 510(k) premarket notification submitted by Modern Medical Equipment Mfg., Ltd. for the device "DISPOSABLE SUCTION AND IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 19, 2010. The device falls under product code FHF (System, Evacuator, Fluid), a Class II device regulated under 21 CFR 876.4370. Modern Medical Equipment Mfg., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2010
Date Received
November 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Evacuator, Fluid
Device Class
Class II
Regulation Number
876.4370
Review Panel
GU
Submission Type

Other clearances by Modern Medical Equipment Mfg., Ltd.

  • K091511 — MODERN MEDICAL RESECTOSCOPE ELECTRODES (January 15, 2010)
  • K070812 — DISPOSABLE LAPAROSCOPIC INSTRUMENT (September 14, 2007)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K050842 — AGCEL WOUND DRESSING,AGCEL BURN DRESSING (August 2, 2006)
  • K043036 — NON-STICK ELECTRODE (May 6, 2005)
  • K033095 — SMOKE EVACUATION ATTACHEMENT (November 17, 2004)
  • K040238 — SOFTSEAL HSG CATHETER (June 22, 2004)
  • K032327 — MODERN MEDICAL BIPOLAR FORCEPS (June 15, 2004)
  • K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS (June 15, 2004)
  • K032965 — LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE (May 13, 2004)

Other clearances for product code FHF

  • K003443 — SUCTION IRRIGATOR (February 1, 2001)
  • K771986 — CATHETER, MEDIASTINAL&PERICARDIAL (October 28, 1977)

FDA data resources