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510(k) K925903

LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION by Birtcher Medical Systems, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1992
Date Received
November 12, 1992
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 Birtcher Medical Systems, Inc.

  • K932779 — BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. (March 21, 1995)
  • K944681 — LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES (December 22, 1994)
  • K932987 — BIRTCHER LAPAROSCOPE AND ACCESSORIES (April 25, 1994)
  • K936114 — BIRTCHER PERICARDIAL KNIVES (April 25, 1994)
  • K931771 — BIRTCHER ENDOSCOPIC CORKSCREW (April 25, 1994)
  • K931654 — BIRTCHER MAGNETIC RETRIEVER (GS-3100) (April 25, 1994)
  • K930887 — BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) (April 25, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K930302 — BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)

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