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510(k) K881937

SURGICAL INSTRUMENTS by Far East Intl. Trading Corp. — Product Code HRQ

K881937 is an FDA 510(k) premarket notification submitted by Far East Intl. Trading Corp. for the device "SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on June 15, 1988. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800. Far East Intl. Trading Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1988
Date Received
May 9, 1988
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 Far East Intl. Trading Corp.

  • K881638 — SURGICAL BLADE (June 15, 1988)

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)
  • K861807 — MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) (May 23, 1986)
  • 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