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510(k) K885311

MENISCUS MENDER II LOOP by Instrument Makar, Inc. — Product Code HWQ

K885311 is an FDA 510(k) premarket notification submitted by Instrument Makar, Inc. for the device "MENISCUS MENDER II LOOP". The FDA issued a decision of Substantially Equivalent on February 9, 1989. The device falls under product code HWQ (Passer), a Class I device regulated under 21 CFR 888.4540. Instrument Makar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1989
Date Received
December 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Passer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Instrument Makar, Inc.

  • K002600 — LITWIN CRUICATE ANCHOR (November 15, 2000)
  • K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT (November 6, 1998)
  • K963396 — BIOSPHERE SUTURE ANCHOR (May 6, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR (July 9, 1996)
  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K930980 — INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW (February 10, 1994)

Other clearances for product code HWQ

  • K970360 — MITEK SUTURE RETROGRADER (March 10, 1997)
  • K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE (May 5, 1993)
  • K923381 — SOFT TISSUE EXPANDER (May 5, 1993)
  • K843592 — VICO MICRO SURGICAL INSTRUMENTS (October 5, 1984)
  • K841622 — SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)
  • K791960 — ROTH-KENNEDY PASSER (October 4, 1979)

FDA data resources