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510(k) K884196

SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) by Disposable Sterile Surgical Instruments, Inc. — Product Code HRQ

K884196 is an FDA 510(k) premarket notification submitted by Disposable Sterile Surgical Instruments, Inc. for the device "SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)". The FDA issued a decision of Substantially Equivalent on November 8, 1988. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1988
Date Received
October 4, 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 for product code HRQ

  • K920298 — DISPOSABLE HEMOSTATS (August 11, 1992)
  • K895683 — BERNARD VESSEL APPROXIMATOR (October 24, 1989)
  • K890245 — SURGICAL HEMOSTATS (January 27, 1989)
  • K881937 — SURGICAL INSTRUMENTS (June 15, 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