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510(k) K840835

STRAITH DRAIN INSERTER by Surgical Technology Laboratories, Inc. — Product Code FZX

K840835 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc. for the device "STRAITH DRAIN INSERTER". The FDA issued a decision of Substantially Equivalent on April 23, 1984. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Surgical Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Surgical Technology Laboratories, Inc.

  • K170582 — Saf-T-Vac Smoke and Fluid Evacuator (April 14, 2017)
  • K021889 — SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (October 16, 2002)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K983754 — STANDARD CHIN (November 20, 1998)
  • K964443 — SURGIFORM ANATOMICAL MALAR (December 20, 1996)
  • K831078 — STRAITH ORAL AIRWAY (June 24, 1983)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)
  • K801074 — STRAITH NASAL IMPLANT (June 17, 1980)
  • K801075 — STRAITH CHISEL FORCEPS (May 20, 1980)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K862564 — A.C.L. GUIDE KIT (August 18, 1986)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 1985)
  • K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (July 11, 1985)
  • K842698 — BRITISH SPINAL FUSION SET (September 12, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)
  • K841297 — TECHMEDICA DRILL GUIDE (April 25, 1984)

FDA data resources