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510(k) K811496

GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. by Narco Scientific — Product Code EMX

K811496 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.". The FDA issued a decision of Substantially Equivalent on Jun 16, 1981. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Narco Scientific has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 16, 1981
Date Received
May 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Balloon, Epistaxis
Device Class
Class I
Regulation Number
874.4100
Review Panel
EN
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)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (Jun 8, 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)

Other clearances for product code EMX

  • K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint (Nov 14, 2022)
  • K041446 — NASALCEASE (Jul 1, 2004)
  • K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL… (May 23, 2000)
  • K993362 — HYLASINE (Mar 13, 2000)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (Sep 14, 1999)
  • K982731 — MEROGEL NASAL DRESSING AND SINUS STENT (Feb 2, 1999)
  • K984069 — ENTAXIS NASAL PACKING (Jan 25, 1999)
  • K981966 — NOSEBLEED NOSECLIP (Aug 14, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (Nov 18, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (Nov 18, 1997)

FDA data resources

Source: FDA 510(k) database entry for K811496. Report a data issue: hello@regdatalab.com.