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510(k) K933319

BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM by Birtcher Medical Systems, Inc. — Product Code GCY

K933319 is an FDA 510(k) premarket notification submitted by Birtcher Medical Systems, Inc. for the device "BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 1993. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. 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
July 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
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)
  • K932987 — BIRTCHER LAPAROSCOPE AND ACCESSORIES (April 25, 1994)
  • K936114 — BIRTCHER PERICARDIAL KNIVES (April 25, 1994)
  • K930887 — BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) (April 25, 1994)
  • K931654 — BIRTCHER MAGNETIC RETRIEVER (GS-3100) (April 25, 1994)
  • K931771 — BIRTCHER ENDOSCOPIC CORKSCREW (April 25, 1994)
  • 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)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933170 — INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (September 16, 1993)

FDA data resources