Home / 510(k) Clearances / K861807

510(k) K861807

MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) by Medcomp Technologies, Inc. — Product Code HRQ

K861807 is an FDA 510(k) premarket notification submitted by Medcomp Technologies, Inc. for the device "MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)". The FDA issued a decision of Substantially Equivalent on May 23, 1986. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800. Medcomp Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1986
Date Received
May 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostat
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Medcomp Technologies, Inc.

  • K861806 — MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT) (May 23, 1986)
  • K861805 — MEDCARE FORCEPS (THUMB, TISSUE) (May 23, 1986)
  • K861804 — MEDCARE SUTURE REMOVAL KIT (May 23, 1986)
  • K860683 — MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPS (March 13, 1986)

Other clearances for product code HRQ

  • K920298 — DISPOSABLE HEMOSTATS (August 11, 1992)
  • K895683 — BERNARD VESSEL APPROXIMATOR (October 24, 1989)
  • K890245 — SURGICAL HEMOSTATS (January 27, 1989)
  • K884196 — SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) (November 8, 1988)
  • K881937 — SURGICAL INSTRUMENTS (June 15, 1988)
  • K844152 — HEMSTATS (November 7, 1984)
  • K843593 — SURGIPRESS SURGICAL LOOP (October 24, 1984)
  • K841514 — SCANLAN VASCU-STATT II APPROXIMATOR (June 5, 1984)
  • K834175 — OP-CON SURG. INSTRUMENTS #11 (January 27, 1984)
  • K831797 — HEMOSTATS (July 19, 1983)

FDA data resources