PISTON SYRINGE WITH NEEDLE— 510(k) K883033

Name: FDA 510(k) clearance K883033
Creator: U.S. Food and Drug Administration
Published: 1988-10-31

Substantially Equivalent

Select Sources, Inc.

FDA 510(k) clearance K883033 for PISTON SYRINGE WITH NEEDLE, Substantially Equivalent on 1988-10-31. Applicant: Select Sources, Inc.. Device class: 2.

Clearance details

Applicant: Select Sources, Inc.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1988-07-19
Decision date: 1988-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Select Sources, Inc.

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K884328 — CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE)1989-04-26
K883705 — FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS1988-11-14
K883078 — INSULIN SYRINGE1988-10-31
K880919 — (CHOICE) ALSO (KONDUM)1988-06-29
K864482 — CHOICE1986-12-22

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.