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510(k) K841623

SLOTTED SOFT-TISSUE INSTRUMENT by Plastafil, Inc. — Product Code HWQ

K841623 is an FDA 510(k) premarket notification submitted by Plastafil, Inc. for the device "SLOTTED SOFT-TISSUE INSTRUMENT". The FDA issued a decision of Substantially Equivalent on July 11, 1984. The device falls under product code HWQ (Passer), a Class I device regulated under 21 CFR 888.4540. Plastafil, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1984
Date Received
April 19, 1984
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 Plastafil, Inc.

  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K841626 — PUNCH (August 27, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841625 — HOOK (August 27, 1984)
  • K841629 — DRILL BIT (August 27, 1984)
  • K841627 — MALLET (August 27, 1984)
  • K841617 — STROVER HOOK (August 27, 1984)
  • K841624 — PROBE (August 27, 1984)
  • K841628 — WIRE (July 23, 1984)

Other clearances for product code HWQ

  • K970360 — MITEK SUTURE RETROGRADER (March 10, 1997)
  • 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)
  • 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