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510(k) K970360

MITEK SUTURE RETROGRADER by Mitek Products — Product Code HWQ

K970360 is an FDA 510(k) premarket notification submitted by Mitek Products for the device "MITEK SUTURE RETROGRADER". The FDA issued a decision of Substantially Equivalent on March 10, 1997. The device falls under product code HWQ (Passer), a Class I device regulated under 21 CFR 888.4540. Mitek Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1997
Date Received
January 31, 1997
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 Mitek Products

  • K013572 — MITEK BIOCRYL INTERFERENCE SCREWS (March 14, 2002)
  • K013781 — RIDIDFIX 2.7MM BTB CROSS PIN KIT (February 6, 2002)
  • K002639 — BIOKNOTLESS ANCHOR (May 11, 2001)
  • K010633 — RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM (May 9, 2001)
  • K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM (February 15, 2001)
  • K003076 — MITEK CUFFTACK (October 27, 2000)
  • K002422 — VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM (August 31, 2000)
  • K002402 — VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM (August 31, 2000)
  • K000936 — VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM (April 19, 2000)
  • K993575 — RESOLVE QUICKANCHOR (December 29, 1999)

Other clearances for product code HWQ

  • K923381 — SOFT TISSUE EXPANDER (May 5, 1993)
  • K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE (May 5, 1993)
  • K885311 — MENISCUS MENDER II LOOP (February 9, 1989)
  • K843592 — VICO MICRO SURGICAL INSTRUMENTS (October 5, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K841622 — 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