VISITEC NEEDLE RANGE (ANESTHESIOLOGY)— 510(k) K811963

Name: FDA 510(k) clearance K811963
Creator: U.S. Food and Drug Administration
Published: 1981-07-16

Substantially Equivalent

Visitec Co.

FDA 510(k) clearance K811963 for VISITEC NEEDLE RANGE (ANESTHESIOLOGY), Substantially Equivalent on 1981-07-16. Applicant: Visitec Co.. Device class: 2.

Clearance details

Applicant: Visitec Co.
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 1981-07-10
Decision date: 1981-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSP

view all

K243690 — SonoMSK2025-07-01
K243682 — SonoPlex STIM; SonoPlex II2025-06-27
K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture2025-06-25
K243525 — SonoTAP and SonoTAP II2025-03-24
K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology2024-11-22

More clearances from Visitec Co.

view all

K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}1995-10-12
K945114 — VISITEC SCLERAL PLUG1995-02-23
K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE1995-02-14
K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS1995-01-17
K942234 — VISITEC PRECISE-POINT1994-07-12

Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.