LITTLE PRISM— 510(k) K913659

Name: FDA 510(k) clearance K913659
Creator: U.S. Food and Drug Administration
Published: 1992-10-14

Substantially Equivalent

Octostop, Inc.

FDA 510(k) clearance K913659 for LITTLE PRISM, Substantially Equivalent on 1992-10-14. Applicant: Octostop, Inc.. Device class: 2.

Clearance details

Applicant: Octostop, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1991-08-07
Decision date: 1992-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Qc., CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPR

view all

K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Octostop, Inc.

view all

K972766 — PIVOTING COMPENSATING FILTERS FOR THE HEAD1997-08-14
K963941 — THE PHARAOH COMPENSATING FILTER1996-11-27
K953246 — OCTOROLL1995-09-29
K952871 — RIDGES PLUS1995-07-20
K942916 — OCTOPAQUE UNIVERSAL1994-09-08

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.