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510(k) K830123

DISP. YANKAVER SURG. SUCTION INSTRUMENT by Narco Scientific — Product Code GCY

K830123 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "DISP. YANKAVER SURG. SUCTION INSTRUMENT". The FDA issued a decision of Substantially Equivalent on Jun 8, 1983. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Narco Scientific has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 8, 1983
Date Received
Jan 11, 1983
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
510(k) Exempt

Other clearances by Narco Scientific

  • K830338 — NARCOTRACE 80 (Dec 22, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (Oct 14, 1983)
  • K831428 — AS 1740 INTERFACE MODULE (Oct 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (Sep 29, 1983)
  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (Sep 12, 1983)
  • K831460 — AS 30/TCP MODULE (Jul 12, 1983)
  • K831028 — TI-1000 TRANSPORT INCUBATOR (May 9, 1983)
  • K823899 — INFANT CARE SYSTEM (Apr 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (Apr 8, 1983)
  • K830654 — INFUSION PUMP RETROGRADE EXTEN. AS 715 (Mar 24, 1983)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (Oct 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (Jun 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (Dec 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (Mar 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (Apr 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (Feb 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION… (Oct 27, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (Oct 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (Oct 5, 1993)

FDA data resources

Source: FDA 510(k) database entry for K830123. Report a data issue: hello@regdatalab.com.