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510(k) K170582

Saf-T-Vac Smoke and Fluid Evacuator by Surgical Technology Laboratories, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2017
Date Received
February 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Surgical Technology Laboratories, Inc.

  • K021889 — SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (October 16, 2002)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K983754 — STANDARD CHIN (November 20, 1998)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K964443 — SURGIFORM ANATOMICAL MALAR (December 20, 1996)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)
  • K831078 — STRAITH ORAL AIRWAY (June 24, 1983)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)
  • K801074 — STRAITH NASAL IMPLANT (June 17, 1980)
  • K801073 — STRAITH CHIN IMPLANTS (May 20, 1980)

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