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510(k) K955168

SURGICAL CUTTER by Promex, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1996
Date Received
November 13, 1995
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 Promex, Inc.

  • K023450 — BIOPSY SITE TISSUE MARKER DEVICE (December 19, 2002)
  • K022634 — CO-AXIAL INTRODUCER NEEDLE (November 6, 2002)
  • K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE (July 24, 2001)
  • K011270 — AUTOMATED CORE BIOPSY DEVICE (June 22, 2001)
  • K001132 — BONE BIOPSY NEEDLE (May 1, 2000)
  • K994272 — AUTOMATED CORE BIOPSY DEVICE (January 7, 2000)
  • K993435 — MANUAL BONE MARROW BIOPSY DEVICE (December 6, 1999)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K972865 — PROMEX ENT TISSUE REMOVAL SYSTEM (September 29, 1997)
  • K961078 — AUTOMATED VITRECTOMY DEVICE (June 14, 1996)

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