Home / 510(k) Clearances / K843593

510(k) K843593

SURGIPRESS SURGICAL LOOP by Syntex Corp. — Product Code HRQ

K843593 is an FDA 510(k) premarket notification submitted by Syntex Corp. for the device "SURGIPRESS SURGICAL LOOP". The FDA issued a decision of Substantially Equivalent on October 24, 1984. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800. Syntex Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1984
Date Received
September 12, 1984
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 Syntex Corp.

  • K920314 — TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) (April 17, 1992)
  • K780997 — AMALGAM ALLOY (July 27, 1978)
  • K780769 — S-100 CT SCANNER (June 2, 1978)
  • K780483 — FIBER OPTIC HANDPIECE (April 28, 1978)
  • K761331 — OPUS I OPTION - FIBER OPTIC L SYSTEM (January 3, 1977)
  • K761332 — HI-SENSITIVITY MODE OPTION FOR S60-1A (December 30, 1976)
  • K761330 — SYNTEX SYSTEM 6000 (December 30, 1976)
  • K761264 — OPTIONS FOR STAR DENTAL OPUS I (December 23, 1976)
  • K761033 — COMPUTERIZED TOMOGRAPHY SCANNER (November 24, 1976)

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)
  • K861807 — MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) (May 23, 1986)
  • K844152 — HEMSTATS (November 7, 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