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510(k) K930302

BIRTCHER SURE CLEAN INSTRUMENT SYSTEM by Birtcher Medical Systems, Inc. — Product Code GCI

K930302 is an FDA 510(k) premarket notification submitted by Birtcher Medical Systems, Inc. for the device "BIRTCHER SURE CLEAN INSTRUMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 1993. The device falls under product code GCI (Laryngoscope, Endoscope), a Class II device regulated under 21 CFR 876.1500. Birtcher Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1993
Date Received
January 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

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)
  • K930887 — BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) (April 25, 1994)
  • K931771 — BIRTCHER ENDOSCOPIC CORKSCREW (April 25, 1994)
  • K932987 — BIRTCHER LAPAROSCOPE AND ACCESSORIES (April 25, 1994)
  • K931654 — BIRTCHER MAGNETIC RETRIEVER (GS-3100) (April 25, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)
  • K925824 — SOLOS FAN RETRACTORS (March 1, 1993)

Other clearances for product code GCI

  • K021747 — DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (August 15, 2002)
  • K003222 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (November 3, 2000)
  • K001362 — KARL STORZ 3D VIDEO SYSTEM (July 17, 2000)
  • K933515 — BOOTY ENDOSCOPE WARMER (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)
  • K922123 — AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (February 1, 1993)
  • K920139 — GLEESON CLOT-BUSTER (April 15, 1992)
  • K915762 — POOLE TIP SUCTION PROBE (March 13, 1992)
  • K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (October 30, 1991)
  • K911829 — ENDOSTAPLE (August 28, 1991)

FDA data resources