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510(k) K932987

BIRTCHER LAPAROSCOPE AND ACCESSORIES by Birtcher Medical Systems, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1994
Date Received
June 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
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)
  • 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)
  • K925824 — SOLOS FAN RETRACTORS (March 1, 1993)

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